Acetaminophen / Hydrocodone Oral Tablet

Brand(s)
Lorcet, Lortab, Maxidone, Norco, Vicodin, Xodol, Zydone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amneal Pharmaceuticals, Llc (2015-09-01)
Oldest Current Product
1982-07-09
License(s)
ANDA
RxNORM
ORAL TABLET\ACETAMINOPHEN:HYDROCODONE
FDAOB
ORAL\TABLET\ACETAMINOPHEN: HYDROCODONE BITARTRATE
ORAL\TABLET\HYDROCODONE BITARTRATE: IBUPROFEN
SPL Active
ORAL\TABLET\ACETAMINOPHEN: HYDROCODONE BITARTRATE
SPL Moiety
ORAL\TABLET\ACETAMINOPHEN: HYDROCODONE

product(s) by strength(s)

acetaminophen 300 mg / hydrocodone bitartrate 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743054VicodinANDAAbbvie Inc.2012-09-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04055621ff13de-6633-4dd3-728e-dc21e574ea7b
2466720192ANDAMikart, Inc.2004-06-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040556b4f4e888-eac6-462f-b2eb-671894653b2d
3596300911XodolANDAShionogi Inc.2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040556c129d9d2-5511-4e14-bd97-6b824ffe0809
4643760643ANDABoca Pharmacal, Llc2011-01-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0904153eff42c0-0c14-4ccb-a3d4-8261f4bfab2b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950775XodolANDARebel Distributors Corp2004-06-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET684530911ANDA040556ddfc14c4-6f0f-4f97-b49f-d516552d3c1f
2422540301XodolANDARebel Distributors Corp2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET596300911ANDA0405567e233783-c467-4ca7-8849-7e1526bb2de0

acetaminophen 300 mg / hydrocodone bitartrate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743041VicodinANDAAbbvie Inc.2012-09-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04065821ff13de-6633-4dd3-728e-dc21e574ea7b
2466720036ANDAMikart, Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040658b4f4e888-eac6-462f-b2eb-671894653b2d
3596300912XodolANDAShionogi Inc.2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040658c129d9d2-5511-4e14-bd97-6b824ffe0809
4643760648ANDABoca Pharmacal, Llc2011-01-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0904153eff42c0-0c14-4ccb-a3d4-8261f4bfab2b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950773XodolANDARebel Distributors Corp2004-06-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET684530912ANDA040658ddfc14c4-6f0f-4f97-b49f-d516552d3c1f
2422540291XodolANDARebel Distributors Corp2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET596300912ANDA0406587e233783-c467-4ca7-8849-7e1526bb2de0
3521250468ANDARemedyrepack Inc.2013-05-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET643760648ANDA09041562915646-8f18-4325-9038-e8713f999dca
4636295191ANDABryant Ranch Prepack2011-01-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET643760648ANDA090415e8b4b810-d564-41cd-807f-424a36d22dae
5636295450ANDABryant Ranch Prepack2011-01-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET643760648ANDA090415f7e786d0-85d5-4b8a-a85a-d6cfc5929c2a
6680840796ANDAAmerican Health Packaging2014-07-312016-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET643760648ANDA090415d40cd079-c5aa-4226-ba0c-4d6de0f00b8e
7680840852ANDAAmerican Health Packaging2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET643760648ANDA0904156cdd1d05-3706-40e2-982c-1f92c3f6c626

acetaminophen 300 mg / hydrocodone bitartrate 7.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743043VicodinANDAAbbvie Inc.2012-09-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04055621ff13de-6633-4dd3-728e-dc21e574ea7b
2466720166ANDAMikart, Inc.2006-03-24ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040556b4f4e888-eac6-462f-b2eb-671894653b2d
3596300913XodolANDAShionogi Inc.2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040556c129d9d2-5511-4e14-bd97-6b824ffe0809
4643760649ANDABoca Pharmacal, Llc2011-01-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0904153eff42c0-0c14-4ccb-a3d4-8261f4bfab2b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950774XodolANDARebel Distributors Corp2004-06-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET684530913ANDA040556ddfc14c4-6f0f-4f97-b49f-d516552d3c1f
2422540114XodolANDARebel Distributors Corp2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET596300913ANDA0405565b50291b-68c7-45a6-ae38-59f137ca7620
3680840990ANDAAmerican Health Packaging2015-03-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET643760649ANDA0904156cdd1d05-3706-40e2-982c-1f92c3f6c626

acetaminophen 325 mg / hydrocodone bitartrate 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004060125ANDAMallinckrodt, Inc.2014-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04040073c1059b-0c7d-42ef-9827-f018858fc447
2004060367ANDAMallinckrodt, Inc.2010-04-222017-07-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04040073c1059b-0c7d-42ef-9827-f018858fc447
3005912612ANDAWatson Laboratories, Inc.2013-03-07ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0401486da96f18-c056-45c2-a1c8-f86484e69d08
4006033887ANDAQualitest Pharmaceuticals2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040355dc769b02-68e1-4ecf-b3de-b043f4cf6ca0
5009046421ANDAMajor2015-02-05ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040148eb28c00f-11ab-442d-9bf3-1e961c336c44
6131070021ANDAAurolife Pharma Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA20101360f43308-1deb-4f05-8f17-aa49ebdcf498
7278080037ANDATris Pharma Inc2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA202214d4caec6d-4af2-4f1c-9add-c0c948b83b16
8504740932LortabANDAUcb, Inc.2014-04-21ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA202214a909231f-b89d-401e-9b02-e5be28414459
9518620217ANDALibertas Pharma, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0901188d8eac2c-0bc5-4101-8f38-b54b29477ab1
10518620229ANDALibertas Pharma, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA090118631a51da-da4d-4cf5-a4f2-c755ede17670
11525440161NorcoANDAActavis Pharma, Inc.2013-03-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0401482f1c9e91-e5e7-4b07-8f56-e3719573ef23
12537460110ANDAAmneal Pharmaceuticals, Llc2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040746e0cefc7b-e81c-4e15-89a0-fe71dc94338b
13576640176ANDACaraco Pharmaceutical Laboratories, Ltd.2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA090118016df82c-a0a5-4f3b-bf73-f7e28f984c95
14683080223LorcetANDAMayne Pharma Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0901187a1411e1-b705-43d9-a305-c020c9e3bf4d
15683080226LorcetANDAMayne Pharma Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA09011871decd86-6797-4dcc-b242-408e7ce582d7

invalid application product(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551542076ANDACardinal Health2009-07-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET680840353ANDA0402487d0d1968-8bf4-4f07-a89f-2ca355740900
2604290574ANDAGolden State Medical Supply, Inc.2013-09-242016-08-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA040084facf04ae-3246-4c27-9ae0-d877d6573d7e
3633040497ANDARnabaxy Pharmaceuticals Inc.2007-08-16ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0408266e153073-ca78-481e-9e9c-0365ee3f3d59

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790116ANDAKaiser Foundations Hospitals2012-04-26ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355983356be-f13a-4710-9742-5e7ed4975760
2001791957ANDAKaiser Foundations Hospitals2008-03-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA040400d4f97887-3353-441e-b1e3-c32bde2a9016
3126340144ANDAApotheca, Inc2009-03-20ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e
4165900118ANDAStat Rx Usa Llc1997-02-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910853ANDA040148598d6c89-e2e4-466d-82c1-5953b14250d7
5216950272ANDARebel Distributors Corp2010-02-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746f6d5fe9a-032f-4cea-8e75-0849878a36bc
6242360359ANDARemedyrepack Inc.2012-12-24ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355cfe44046-9533-4f5a-9671-1ab09c4e12f6
7332610058ANDAAidarex Pharmaceuticals Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA0403553a1e0443-c06c-4945-8a9d-d6f764ca68a5
8353560648ANDALake Erie Medical Dba Quality Care Products Llc2012-04-03ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA04040061c36d81-8f1a-446d-8db5-72c3635589fc
9353560706ANDALake Erie Medical Dba Quality Care Products Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA040400eda68f78-442e-4062-a799-600fafbd389b
10353560795ANDALake Erie Medical Dba Quality Care Products Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070021ANDA2010131669c4be-67c8-4e24-a3c9-6f5dff3dea3e
11422540214ANDARebel Distributors Corp2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640176ANDA0901185f215257-7c82-478f-a263-6fb37b438d69
12425490514ANDAStat Rx Usa Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA040400c8be6c8d-7c55-459b-bc16-7651c2fd6e27
13430630327ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746d0fa7f7f-2d7b-4338-87db-72dca4ead87b
14430630339ANDAPd-Rx Pharmaceuticals, Inc.1997-02-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910853ANDA040148e5b4d46d-ef77-4a36-b038-80288f03d43f
15433530159ANDAAphena Pharma Solutions - Tennessee, Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355d22a77c7-7abe-492c-894a-954fb4947fd7
16458650411ANDAMedsource Pharmaceuticals2011-07-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA04040053b3ed76-db40-4aa8-8c55-21991d557b42
17493490578ANDARemedyrepack Inc.2010-12-07ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640176ANDA090118a5b9f4f8-db72-4093-a6bc-63fbf89918ec
18499990169ANDALake Erie Medical Dba Quality Care Products Llc2011-11-03ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910853ANDA040148d321f279-a696-495d-932e-ea3e18c6c88a
19500900729ANDAA-S Medication Solutions Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA0403554789b848-b422-4576-a34d-669ac337e00b
20502680402ANDAAvpak2014-09-15ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA0407465174bd9a-b777-a6e3-f72f-c16082ee67d3
21502680408ANDAAvpak2006-08-252016-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746fdd25fee-0a2b-1297-b87b-07c47f09c8e2
22504363171ANDAUnit Dose Services2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA0403557a2abfaa-8758-4b76-86b0-68ebdab9706c
23510790779ANDAMylan Institutional Inc.2007-09-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA04035504562feb-471d-4cae-832a-47eb31603b30
24521250295ANDARemedyrepack Inc.2013-05-07ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910853ANDA040148c6da0e08-0969-4c89-bca6-f8b65e08df62
25545695240ANDAA-S Medication Solutions Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA04035508ff26ca-bbc1-4d53-a4d3-865f810cfb69
26545696438ANDAA-S Medication Solutions Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355a700d066-9b53-4f71-b967-b597785ecf1f
27548684034NorcoANDAPhysicians Total Care, Inc.1998-05-13ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET525440539ANDA04014844b86290-2391-4b02-abd4-b1c0c611891e
28548684974ANDAPhysicians Total Care, Inc.2004-01-13ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA0404008f5d00de-3b9b-46d4-b374-1cf329a4c1db
29548686407ANDAPhysicians Total Care, Inc.2013-10-11ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355499a7ebd-912b-4bbb-908a-ff40e589ff70
30551540840ANDACardinal Health2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355bf252729-96fa-4ccb-8dce-856f9af0bd45
31551541150NorcoANDACardinal Health1997-02-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET525440539ANDA0401481c7ff5b9-6698-4e8c-9060-2abcd3fb0dcf
32551546625ANDACardinal Health2013-06-26ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET680840100ANDA040148a15f62e4-fa53-4235-a719-6f099d9b7927
33551547273ANDACardinal Health2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA0404007742d54e-89f7-4911-92d6-ca883aa8269a
34551547554ANDACardinal Health2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA0404003bf81da9-62bc-4c82-b8fc-c45d270c5681
35552890737ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746d6a4da3b-5030-40af-a84f-7a9889d1cf25
36557000170ANDALake Erie Medical Dba Quality Care Products Llc2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640176ANDA090118501b8db1-88e6-478a-b00f-94e3b8eec941
37557000260ANDALake Erie Medical Dba Quality Care Products Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355851e23af-5b5e-4dd5-8bd2-da0592b32ac2
38607600388ANDASt Marys Medical Park Pharmacy2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355e53f76e8-3772-4576-a3b9-1bcfa96e5239
39619190118ANDADirect Rx2014-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA0407461ac64001-75dd-4fba-9a89-9969364e5c9a
40619190156ANDADirect Rx2014-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA0403552dc8b182-88ae-4776-a17d-b61bb620768c
41631870120ANDAProficient Rx Lp2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746bab189ed-ff83-453c-a243-7ff052b2e491
42636295432ANDABryant Ranch Prepack2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA04035500f1e7e6-4f94-4bf4-a726-0b4ffbf6d1b1
43636295434ANDABryant Ranch Prepack2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746878efd95-3026-4583-adc2-1fbcb5566441
44638740834ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355047af99e-1c90-4de3-9116-b29ac4cd85d3
45650840453ANDARxpak Division Of Mckesson Corporation2013-06-24ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET525440161ANDA040148d08cc0ab-4cb5-4290-8d46-5d8b66e8472e
46663360444ANDADispensing Solutions, Inc.2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355930b3a2b-b79d-4290-b358-bd1bb214c96b
47672960499ANDARedpharm Drug Inc.2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746e2f2b9e3-2cb6-4330-8446-5c01ebe1fa19
48672960804ANDARedpharm Drug Inc.2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA04035500eff641-4b66-4bfc-9310-5a76c257e007
49675440670ANDAAphena Pharma Solutions - Tennessee, Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA04040007b3ba11-6c4e-4fda-b322-cfbfd9f81021
50680840100ANDAAmerican Health Packaging2013-06-252016-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005912612ANDA0401481ea23e17-2399-4656-b055-2ad9cbdb6388
51680840884ANDAAmerican Health Packaging2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005912612ANDA040148fc3c3d40-69ba-4273-b7a1-cf715b68478d
52683870235ANDAKeltman Pharmaceuticals Inc.2010-11-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA04074645b2deca-b5d4-4c5d-aa6a-e7063aaa44fb
53687889141ANDAPreferred Pharmaceuticals, Inc.2011-07-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033887ANDA040355f678594f-1e1a-4fed-8ff3-6c64a6fa5cf9
54687889297ANDAPreferred Pharmaceuticals, Inc.2015-04-21ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460110ANDA040746b85df27f-c6e2-4247-b24f-052cbfb408dd
55687889413ANDAPreferred Pharmaceuticals, Inc.2014-05-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070021ANDA2010136ccf6d8d-b301-433d-aec0-396b5d3e14ad
56762370177ANDAMckesson Contract Packaging2011-10-05ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA040400a6b39b0c-3fb5-461c-aeae-3653cea7b121
57762370515ANDAMckesson Contract Packaging2011-10-05ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060367ANDA0404001b613496-07ab-4e62-9e80-1dcebea58ed6

acetaminophen 325 mg / hydrocodone bitartrate 2.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912171ANDAWatson Laboratories, Inc.2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040148a3fff41b-9eab-43b2-8e7f-cb1eaf9042bc
2138110657ANDATrigen Laboratories, Inc.2014-02-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0408462bb06f4f-ed55-4a51-8782-465dd45e60dc
3466720092ANDAMikart, Inc.2010-06-09ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040846f27f8c7c-ede6-4116-9b03-6be5357c35f1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1332610881ANDAAidarex Pharmaceuticals Llc2012-05-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA04084603aea0d1-c808-40ae-9605-166733202166
2353560766ANDALake Erie Medical Dba Quality Care Products Llc2012-05-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA04084644ed0a3b-1614-42f0-8a28-c836686167aa
3422540300ANDARebel Distributors Corp2012-05-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA040846a05c255c-6e0b-4e86-b907-738b777fc524
4504363912ANDAUnit Dose Services2012-05-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA040846f410ba48-2c6c-42e0-9802-ecc733cad9b0
5557000216ANDALake Erie Medical Dba Quality Care Products Llc2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005912171ANDA0401487221396f-4f3a-428a-9252-d451511b94e4
6636295428ANDABryant Ranch Prepack2012-05-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA04084606cd8ce6-8416-4747-b563-d88814539e12
7687889754ANDAPreferred Pharmaceuticals, Inc.2012-08-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA0408466f367d9b-7141-46d8-a3a3-5a241e167259
8765191011ANDAH.J. Harkins Company, Inc.2012-05-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET762181828ANDA0408464f505b2a-45a2-4d34-96f6-dedb574cb508

acetaminophen 325 mg / hydrocodone bitartrate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004060123ANDAMallinckrodt, Inc.2014-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04040973c1059b-0c7d-42ef-9827-f018858fc447
2004060365ANDAMallinckrodt, Inc.2010-04-222018-07-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04040973c1059b-0c7d-42ef-9827-f018858fc447
3005913202ANDAWatson Laboratories, Inc.1997-06-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040099fa32969f-7210-47ec-bbd1-f62bea8989a7
4006033890ANDAQualitest Pharmaceuticals2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040655dc769b02-68e1-4ecf-b3de-b043f4cf6ca0
5009046419ANDAMajor2015-02-05ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04009900fda976-83fd-4b58-8ef7-1bf04e9c5a00
6131070019ANDAAurolife Pharma Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA20101360f43308-1deb-4f05-8f17-aa49ebdcf498
7278080035ANDATris Pharma Inc2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA202214d4caec6d-4af2-4f1c-9add-c0c948b83b16
8504740930LortabANDAUcb, Inc.2014-04-21ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA202214a909231f-b89d-401e-9b02-e5be28414459
9518620215ANDALibertas Pharma, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0901188d8eac2c-0bc5-4101-8f38-b54b29477ab1
10518620227ANDALibertas Pharma, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA090118631a51da-da4d-4cf5-a4f2-c755ede17670
11525440913NorcoANDAActavis Pharma, Inc.1997-06-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040099aaef2d01-126d-4aab-9b2a-eee31a769150
12537460109ANDAAmneal Pharmaceuticals, Llc2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04073662be4147-6a72-49e5-9338-10887c65a93a
13543480066ANDAPharmpak, Inc.2014-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040736fcff467e-ddcb-48d1-ac8b-a8e4435eebb2
14576640126ANDACaraco Pharmaceutical Laboratories, Ltd.2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA090118016df82c-a0a5-4f3b-bf73-f7e28f984c95
15683080221LorcetANDAMayne Pharma Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0901187a1411e1-b705-43d9-a305-c020c9e3bf4d
16683080224LorcetANDAMayne Pharma Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA09011871decd86-6797-4dcc-b242-408e7ce582d7
17683870236NorcoANDAKeltman Pharmaceuticals Inc.2008-02-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040099566bd196-3c0c-4f05-9e2e-4803ad3126d4

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790112ANDAKaiser Foundations Hospitals2012-04-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409d4f97887-3353-441e-b1e3-c32bde2a9016
2001790113ANDAKaiser Foundations Hospitals2012-04-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655983356be-f13a-4710-9742-5e7ed4975760
3004407605ANDALiberty Pharmaceuticals, Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406552c17f3d1-2a00-45b1-82f3-420f778ee7c0
4126340264ANDAApotheca, Inc2009-03-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005913202ANDA0400992ec4d6a5-d2a3-4c91-9d61-afeb3abd17af
5165900494ANDAStat Rx Usa Llc1997-06-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005913202ANDA04009923254286-73f1-4aa5-b2b5-94967516bbf4
6216950268ANDARebel Distributors Corp2009-09-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA076642b935625d-e9e6-4b5b-a40a-3f4e7f01fa45
7332610053ANDAAidarex Pharmaceuticals Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406553a1e0443-c06c-4945-8a9d-d6f764ca68a5
8353560796ANDALake Erie Medical Dba Quality Care Products Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070019ANDA2010131669c4be-67c8-4e24-a3c9-6f5dff3dea3e
9422540340ANDARebel Distributors Corp2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640126ANDA090118a46da71a-5fe1-4021-b866-4a806a12efa8
10425490556ANDAStat Rx Usa Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409c8be6c8d-7c55-459b-bc16-7651c2fd6e27
11430630091ANDAPd-Rx Pharmaceuticals, Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406553aba54cb-3cd9-480b-aca0-17ac90373c38
12433530324ANDAAphena Pharma Solutions - Tennessee, Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409b6c6ee17-6414-4974-8915-418b16f64545
13433530734ANDAAphena Pharma Solutions - Tennessee, Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655d22a77c7-7abe-492c-894a-954fb4947fd7
14458650605ANDAMedsource Pharmaceuticals2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406551e171e42-6083-4873-e054-00144ff88e88
15493490357ANDARemedyrepack Inc.2011-07-08ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640126ANDA090118ed5b25b0-fd12-48c2-96ac-c136357ebd43
16493490671ANDARemedyrepack Inc.2011-03-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA04065522cb6a7b-9d83-4d10-aaa5-cd950acc20a7
17493490689ANDARemedyrepack Inc.2011-03-16ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736dc42d9f2-0821-4637-8e0f-7de431fea560
18499990608ANDALake Erie Medical Dba Quality Care Products Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409d4aa02ce-82ae-47b5-bd20-71d77293fec3
19500900843ANDAA-S Medication Solutions Llc2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA0407367398cedf-ed0c-40eb-a385-b94ceb4a22c2
20500900844ANDAA-S Medication Solutions Llc2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA0407365e8a1905-dc47-4786-a6be-c66549767673
21500901517ANDAA-S Medication Solutions Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406554789b848-b422-4576-a34d-669ac337e00b
22500901518ANDAA-S Medication Solutions Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655561043e9-3e09-4919-bf55-53907b3af9e5
23502680401ANDAAvpak2014-09-15ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA0407365174bd9a-b777-a6e3-f72f-c16082ee67d3
24502680403ANDAAvpak2006-08-252016-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736fdd25fee-0a2b-1297-b87b-07c47f09c8e2
25504363918ANDAUnit Dose Services2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640126ANDA0901184bdf818e-4951-40dc-bf1b-71ab58a79baa
26510790777ANDAMylan Institutional Inc.2007-09-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA04065504562feb-471d-4cae-832a-47eb31603b30
27514070500ANDAGolden State Medical Supply, Inc.2013-12-162016-08-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA04040931727266-7205-45e0-8a23-9646d66815b9
28516550899ANDANorthwind Pharmaceuticals, Llc2015-05-11ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655c9e88716-d0f7-46b1-8d66-5053c045e0fd
29516550900ANDANorthwind Pharmaceuticals, Llc2014-06-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640126ANDA0901180b32a79b-ab42-4020-9c13-064284d95258
30529590737ANDAH.J. Harkins Company, Inc.2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736221c6c53-35b8-4bd7-adfc-f8200b9f49c1
31545695523ANDAA-S Medication Solutions Llc2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736d5fe9ecf-461d-4fe9-8b7d-7ba7c128aff3
32545698314ANDAA-S Medication Solutions Llc2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA0407361123ebe3-a565-4edb-958c-a3ccbdc547f1
33548685146ANDAPhysicians Total Care, Inc.2004-09-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA0404098f5d00de-3b9b-46d4-b374-1cf329a4c1db
34551541183ANDACardinal Health2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA04073606fc5b52-05dc-4c97-82a1-47b7ec2e3ee7
35551541497ANDACardinal Health2011-11-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET637390532ANDA0406552deaa2e4-ef15-4d14-b93b-2225ebf02559
36551547269ANDACardinal Health2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA0404097742d54e-89f7-4911-92d6-ca883aa8269a
37551547555ANDACardinal Health2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA0404093bf81da9-62bc-4c82-b8fc-c45d270c5681
38552890997ANDAPd-Rx Pharmaceuticals, Inc.2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736672ffaa8-1084-4d1a-b880-267775e576e0
39557000261ANDALake Erie Medical Dba Quality Care Products Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655851e23af-5b5e-4dd5-8bd2-da0592b32ac2
40604290572ANDAGolden State Medical Supply, Inc.2011-05-192016-08-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409fb68d701-a7c7-4817-8c92-b1a7e8a4282b
41607600202ANDASt Marys Medical Park Pharmacy2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406550b212d93-8c64-400f-b8cd-242731f2252f
42619190494ANDADirect Rx2014-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736fa2a09a8-7835-4261-a9b1-b35adab27de7
43631870112ANDAProficient Rx Lp2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA04073650be5d00-758e-4d01-8e78-40a60dbe67e5
44636295422ANDABryant Ranch Prepack2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736a200d099-fa55-4ef1-b8d7-936a7da1db00
45637390532ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-11-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406551cfb6720-c52d-4d84-b4a5-b63570b239bd
46637390704ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-11-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655107033c5-679b-487c-aa33-49e8c35c6419
47663360670ANDADispensing Solutions, Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA04065559e7db61-9ce5-416c-b576-87babe94dbdf
48672960362ANDARedpharm Drug Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409501c16ee-31e0-445d-8187-6cb0341c135e
49672960515ANDARedpharm Drug Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA040655c7a9280e-e713-4773-b4bd-aabec9cff63a
50680840368ANDAAmerican Health Packaging2009-09-222016-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA0407363fc4c51f-11ed-4069-a938-c4c444270503
51680840895ANDAAmerican Health Packaging2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA040736673c132c-fc85-4ddd-b50b-45f93f01fd90
52687889137ANDAPreferred Pharmaceuticals, Inc.2009-09-09ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033890ANDA0406557510a9ec-6ef0-4610-8dce-8286a043d09c
53687889250ANDAPreferred Pharmaceuticals, Inc.2014-11-03ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460109ANDA0407361bf4d591-b3c6-42c6-b038-ef1f52cfdf68
54687889398ANDAPreferred Pharmaceuticals, Inc.2014-06-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070019ANDA2010139009099c-67a1-439d-8d0d-df8c9e26ed5f
55762370180ANDAMckesson Contract Packaging2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA040409a6b39b0c-3fb5-461c-aeae-3653cea7b121
56762370336ANDAMckesson Contract Packaging2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060365ANDA0404091b613496-07ab-4e62-9e80-1dcebea58ed6

acetaminophen 325 mg / hydrocodone bitartrate 7.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004060124ANDAMallinckrodt, Inc.2014-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04040573c1059b-0c7d-42ef-9827-f018858fc447
2004060366ANDAMallinckrodt, Inc.2010-04-222017-05-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04040573c1059b-0c7d-42ef-9827-f018858fc447
3005912605ANDAWatson Laboratories, Inc.2013-03-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0401486da96f18-c056-45c2-a1c8-f86484e69d08
4006033891ANDAQualitest Pharmaceuticals2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040656dc769b02-68e1-4ecf-b3de-b043f4cf6ca0
5009046420ANDAMajor2015-02-05ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040148eb28c00f-11ab-442d-9bf3-1e961c336c44
6131070020ANDAAurolife Pharma Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA20101360f43308-1deb-4f05-8f17-aa49ebdcf498
7278080036ANDATris Pharma Inc2014-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA202214d4caec6d-4af2-4f1c-9add-c0c948b83b16
8466720147ANDAMikart, Inc.2003-01-20ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04043259a558d4-8f4a-4bf0-b7a5-0ca2f7eb7f11
9504740931LortabANDAUcb, Inc.2014-04-21ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA202214a909231f-b89d-401e-9b02-e5be28414459
10518620216ANDALibertas Pharma, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0901188d8eac2c-0bc5-4101-8f38-b54b29477ab1
11518620228ANDALibertas Pharma, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA090118631a51da-da4d-4cf5-a4f2-c755ede17670
12525440162NorcoANDAActavis Pharma, Inc.2013-03-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0401482f1c9e91-e5e7-4b07-8f56-e3719573ef23
13576640170ANDACaraco Pharmaceutical Laboratories, Ltd.2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA090118016df82c-a0a5-4f3b-bf73-f7e28f984c95
14683080222LorcetANDAMayne Pharma Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA0901187a1411e1-b705-43d9-a305-c020c9e3bf4d
15683080225LorcetANDAMayne Pharma Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA09011871decd86-6797-4dcc-b242-408e7ce582d7

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340260ANDAApotheca, Inc2014-01-08ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640170ANDA090118fe743045-6501-4d99-ae8d-7b0f3e27c656
2165900114ANDAStat Rx Usa Llc2000-09-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005913203ANDA040148598d6c89-e2e4-466d-82c1-5953b14250d7
3216950386ANDARebel Distributors Corp2009-03-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET576640170ANDA0901185dad6fbc-2e4d-49dc-8810-721a7701f01e
4332610055ANDAAidarex Pharmaceuticals Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406563a1e0443-c06c-4945-8a9d-d6f764ca68a5
5353560797ANDALake Erie Medical Dba Quality Care Products Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070020ANDA2010131669c4be-67c8-4e24-a3c9-6f5dff3dea3e
6425490557ANDAStat Rx Usa Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA040405c8be6c8d-7c55-459b-bc16-7651c2fd6e27
7430630265ANDAPd-Rx Pharmaceuticals, Inc.2000-09-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005913203ANDA040148d0dc56ed-889f-4196-9d9d-b6840d8ad9a7
8433530503ANDAAphena Pharma Solutions - Tennessee, Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA040656d22a77c7-7abe-492c-894a-954fb4947fd7
9433530721ANDAAphena Pharma Solutions - Tennessee, Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA040405b6c6ee17-6414-4974-8915-418b16f64545
10458650419ANDAMedsource Pharmaceuticals2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406561e171e42-6083-4873-e054-00144ff88e88
11499990609ANDALake Erie Medical Dba Quality Care Products Llc2011-11-09ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA04040569760d70-a6d5-4a00-9437-dce466e103a2
12500901084ANDAA-S Medication Solutions Llc2012-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070020ANDA201013bfeb838d-f963-490c-9dcc-c729ea779b52
13504360160ANDAUnit Dose Services2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406563af5a343-9776-4811-8f03-7433e50cf618
14510790778ANDAMylan Institutional Inc.2007-09-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA04065604562feb-471d-4cae-832a-47eb31603b30
15514070501ANDAGolden State Medical Supply, Inc.2013-12-162015-12-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA04040531727266-7205-45e0-8a23-9646d66815b9
16516550055ANDANorthwind Pharmaceuticals, Llc2014-10-15ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA040656675b1685-cd11-452e-9f88-31b5566850e0
17545696027ANDAA-S Medication Solutions Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA04065608ff26ca-bbc1-4d53-a4d3-865f810cfb69
18548685167ANDAPhysicians Total Care, Inc.2004-11-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA040405ab52a549-8ecc-441a-8733-0fda146e9932
19551540837ANDACardinal Health2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA040656bf252729-96fa-4ccb-8dce-856f9af0bd45
20551547261ANDACardinal Health2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA0404053bd7331c-11b4-4dac-984d-bf02cc5b405a
21551547271ANDACardinal Health2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA0404057742d54e-89f7-4911-92d6-ca883aa8269a
22552890802ANDAPd-Rx Pharmaceuticals, Inc.2000-09-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005913203ANDA040148f3c1201e-19cb-42f1-ae37-d8faf02f6eb0
23557000262ANDALake Erie Medical Dba Quality Care Products Llc2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA040656851e23af-5b5e-4dd5-8bd2-da0592b32ac2
24604290573ANDAGolden State Medical Supply, Inc.2011-05-192015-12-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA040405fb68d701-a7c7-4817-8c92-b1a7e8a4282b
25607600032ANDASt Marys Medical Park Pharmacy2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406560b212d93-8c64-400f-b8cd-242731f2252f
26619190114ANDADirect Rx2014-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406561dce86ff-e194-418f-976f-4dd13c37174a
27619190208ANDADirect Rx2015-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070020ANDA20101336710b35-419c-4e64-8bd1-29b81a4c8e03
28631870137ANDAProficient Rx Lp2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA040656681d604f-6b33-4d7c-93ae-a5458062ced9
29636295436ANDABryant Ranch Prepack2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA0404090b195eb3-b51f-41b1-b869-29c1e7531457
30663360115ANDADispensing Solutions, Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406562501e752-f5fe-40c0-bdc3-a961fe9c42f9, a344a83d-66e7-4f71-b819-1e636b089486
31672960589ANDARedpharm Drug Inc.2006-01-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406560baf67c2-c1ef-4b6d-9498-62353e3bcd7a
32680840601ANDAAmerican Health Packaging2012-08-302016-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA040656a91445a5-395c-4e88-afa7-3dba1f735775
33680840863ANDAAmerican Health Packaging2014-10-062016-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406566c119874-2a82-421b-9f65-5de5776baadc
34687889125ANDAPreferred Pharmaceuticals, Inc.2011-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033891ANDA0406563287d19f-b69e-4035-9704-7c507ad6fa97
35687889395ANDAPreferred Pharmaceuticals, Inc.2014-11-19ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET131070020ANDA2010136ccf6d8d-b301-433d-aec0-396b5d3e14ad
36762370182ANDAMckesson Contract Packaging2011-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA040405a6b39b0c-3fb5-461c-aeae-3653cea7b121
37762370400ANDAMckesson Contract Packaging2011-10-06ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060366ANDA0404051b613496-07ab-4e62-9e80-1dcebea58ed6

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900350ZydoneANDAStat Rx Usa Llc1998-12-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET634810669ANDA0402884aa8c5b1-d71f-4aa8-92b2-1cde266da467

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004060363ANDAMallinckrodt, Inc.2010-04-222016-09-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04020173c1059b-0c7d-42ef-9827-f018858fc447
2216950273ANDARebel Distributors Corp2010-07-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460119ANDA000000ef97de17-13df-40af-bbb9-77135df01e44
3216950987ANDARebel Distributors Corp2007-02-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET651620120ANDA0408132971483d-f1dd-4908-9afb-800a735c5402
4422540079ANDARebel Distributors Corp2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033888ANDA0403560e7494b0-c061-49e8-bb02-3fd3bc960740
5422540346ANDARebel Distributors Corp2007-02-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460119ANDA0408134b8f1462-d3f0-40f1-9f4a-7e54171fb8b8
6493490006ANDARemedyrepack Inc.2010-07-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460119ANDA04072941389699-1558-40a1-aba5-71f424ef2e3c
7493490080ANDARemedyrepack Inc.2010-11-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460119ANDA04081365c64f8e-fe91-4920-9609-254accc24c0a
8499990327ANDALake Erie Medical Dba Quality Care Products Llc2012-02-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060363ANDA040201783be2dd-5648-4549-8ebf-5067f1b1e5f1
9545695481ANDAA-S Medication Solutions Llc2000-05-312013-12-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04035608ff26ca-bbc1-4d53-a4d3-865f810cfb69
10548684237ANDAPhysicians Total Care, Inc.2000-07-272014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060363ANDA0402018f5d00de-3b9b-46d4-b374-1cf329a4c1db
11551547202LortabANDACardinal Health1996-01-26ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740910ANDA040100bf4631fb-5ed9-4c21-92a6-c0e5f800bbae
12551547274ANDACardinal Health2010-04-222015-08-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060363ANDA0402017742d54e-89f7-4911-92d6-ca883aa8269a
13638740293ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033888ANDA040356047af99e-1c90-4de3-9116-b29ac4cd85d3
14650840285LortabANDARxpak Division Of Mckesson Corporation2002-02-28ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740910ANDA040100a11c2438-769f-4ddc-85f4-fcd4b3755465
15663360408ANDADispensing Solutions, Inc.2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033888ANDA0403560045ec13-789a-40a1-ac1f-8c29049cfd13
16672960649ANDARedpharm Drug Inc.2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033888ANDA0403562b9c339a-a084-4172-ba76-b99cf35d5d74
17675440025ANDAAphena Pharma Solutions - Tennessee, Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060363ANDA04020107b3ba11-6c4e-4fda-b322-cfbfd9f81021
18762370178ANDAMckesson Contract Packaging2011-10-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060363ANDA040201a6b39b0c-3fb5-461c-aeae-3653cea7b121

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340978ANDAApotheca, Inc2008-07-012014-12-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910540ANDA040148fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e
2165900119ANDAStat Rx Usa Llc1997-02-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910540ANDA040148598d6c89-e2e4-466d-82c1-5953b14250d7
3425490653ANDAStat Rx Usa Llc1997-02-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910540ANDA0401484db32036-15bc-4ea0-9d0f-4760111a4462
4521250695ANDARemedyrepack Inc.2013-09-04ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005912609ANDA0401488d91beae-1776-472e-86f8-47a87169d80f
5636294273ANDABryant Ranch Prepack2013-01-04ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005912609ANDA040148513f1287-93aa-4675-89af-e8e55b77e5b2
6636295435ANDABryant Ranch Prepack2013-01-04ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005912609ANDA040148d5eef594-08e6-41ca-a2b6-16fe989a649a

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900112ANDAStat Rx Usa Llc1991-08-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910388ANDA081079598d6c89-e2e4-466d-82c1-5953b14250d7
2216950579ANDARebel Distributors Corp1996-02-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033880ANDA040144029f39ed-ec6f-4fdc-bc0d-abfb6784cc91
3493490636ANDARemedyrepack Inc.2011-04-08ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET00591038801ANDA040123bf25b17d-5017-4c00-a431-517119d1814c
4636294207ANDABryant Ranch Prepack1991-08-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910388ANDA0810798c09aa83-9545-4ebd-bd62-5692fcbb2016
5663360019ANDADispensing Solutions, Inc.1996-02-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033880ANDA0401446c7290b2-5ce6-4101-a177-217b2c7e5415

acetaminophen 500 mg / hydrocodone bitartrate 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1543480013ANDAPharmpak, Inc.2014-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040099dcac1bee-8f12-4c84-b5cb-fa3407205283

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791026ANDAKaiser Foundations Hospitals2011-03-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA089971983356be-f13a-4710-9742-5e7ed4975760
2004060357ANDAMallinckrodt, Inc.2010-04-222017-09-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA08916073c1059b-0c7d-42ef-9827-f018858fc447
3004407610ANDALiberty Pharmaceuticals, Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA089160247780cf-4dbf-472c-b39b-dbb79e300387
4165900113ANDAStat Rx Usa Llc2010-01-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA089160a1e69243-a744-4746-a574-58b0c167b11c
5216950269ANDARebel Distributors Corp2010-02-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460111ANDA040729f6d5fe9a-032f-4cea-8e75-0849878a36bc
6242360068ANDARemedyrepack Inc.2012-09-10, 2013-09-27ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA040084, ANDA0891601c6a1c66-8225-473b-bc48-ab11940ac03f, 30fb99fb-1b00-4309-bcbc-8ec5ff171fdb
7242360432ANDARemedyrepack Inc.2012-08-27ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910349ANDA089883eed5e8f6-d96a-4222-aabf-73ed7d975df2
8353560654ANDALake Erie Medical Dba Quality Care Products Llc2012-04-03ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910349ANDA089883549be5fb-abb3-48e8-968e-0830f93a1fc8
9422540100ANDARebel Distributors Corp1988-12-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA0899710e7494b0-c061-49e8-bb02-3fd3bc960740
10425490609ANDAStat Rx Usa Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA089160c8be6c8d-7c55-459b-bc16-7651c2fd6e27
11458650407ANDAMedsource Pharmaceuticals2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA08916077e4446e-78a0-4596-9679-15938eb0f892
12499990017ANDALake Erie Medical Dba Quality Care Products Llc2011-11-07ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA089160d7f92280-7a55-4a12-a42b-2ea21a29230c
13499990051VicodinANDALake Erie Medical Dba Quality Care Products Llc1983-01-07ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET000741949ANDA08805860ac290f-fa72-40bc-807b-2c18ffe10eb0
14504363914ANDAUnit Dose Services1988-12-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA089971b933d7c4-0766-4a27-93db-ed0ce6028306
15548680071ANDAPhysicians Total Care, Inc.2008-10-282014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA0891608f5d00de-3b9b-46d4-b374-1cf329a4c1db
16551541603VicodinANDACardinal Health1983-01-07ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET000741949ANDA088058eeddb567-4fce-451e-abe1-1f74fb5aebf7
17551547204LortabANDACardinal Health1982-07-09ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740902ANDA087722b990f540-a718-49de-98df-95c5a7d07e6f
18551547252ANDACardinal Health2010-04-222014-07-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA0891603bf81da9-62bc-4c82-b8fc-c45d270c5681
19551547270ANDACardinal Health2010-04-222016-07-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA0891607742d54e-89f7-4911-92d6-ca883aa8269a
20604290509ANDAGolden State Medical Supply, Inc.2011-05-192017-07-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA0400848a9414c0-93cb-41a3-984e-e2e3708bd499
21637390455ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-07-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA089160771d50f8-7fdc-4474-a2ad-ca7075d0e47d
22637390801ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-07-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET650840444ANDA08916088a7a828-f3f6-4b10-bb24-60903d5b5579
23638740203ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA089971047af99e-1c90-4de3-9116-b29ac4cd85d3
24650840287LortabANDARxpak Division Of Mckesson Corporation2002-02-28ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740902ANDA0877226e48680d-b4ea-4eca-86ab-d9eb3434855b
25650840444ANDARxpak Division Of Mckesson Corporation2010-09-13ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA0891609fb987db-408c-4310-89ee-228bf56bc3c6
26663360442ANDADispensing Solutions, Inc.1988-12-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA0899711b733f85-dafb-4242-be8a-65540d956380
27670460925ANDAContract Pharmacy Services-Pa2011-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910349ANDA089883e45a941e-4f98-43ca-adae-9e1c02f949e4
28670460926ANDAContract Pharmacy Services-Pa2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA089160ab6b4c39-b2d4-4c63-8821-b0560f781287
29670460927ANDAContract Pharmacy Services-Pa2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460111ANDA040729deaf83c4-6df1-4f11-82cc-9fed561e8b40
30670460928ANDAContract Pharmacy Services-Pa1988-12-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA0899712ebcbba3-36bb-49ec-8625-43d60fb730ee
31672960466ANDARedpharm Drug Inc.2010-01-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040729714fb533-a412-4be1-90f5-44f5e40796ac
32672960470ANDARedpharm Drug Inc.1998-12-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA08997130e299ce-ad48-422a-bc00-4cb565390f22
33675440023ANDAAphena Pharma Solutions - Tennessee, Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA08916007b3ba11-6c4e-4fda-b322-cfbfd9f81021
34759210881ANDALife Line Home Care Services, Inc.1988-12-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033881ANDA0899714bbf4358-e149-4b21-ab3a-b0c17cc43afc
35762370181ANDAMckesson Contract Packaging2011-10-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060357ANDA089160a6b39b0c-3fb5-461c-aeae-3653cea7b121

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004060358ANDAMallinckrodt, Inc.2010-04-222018-09-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04020173c1059b-0c7d-42ef-9827-f018858fc447
2126340783ANDAApotheca, Inc2006-05-02ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910385ANDA081080d29d8c9c-c3be-4428-99e5-017d030a46f2
3165900115ANDAStat Rx Usa Llc1991-08-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910385ANDA081080598d6c89-e2e4-466d-82c1-5953b14250d7
4165900636LortabANDAStat Rx Usa Llc1989-08-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740907ANDA089699f508d99b-92f7-4dcc-89bb-83d29ed988b3
5216950270ANDARebel Distributors Corp2010-02-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460112ANDA040748f6d5fe9a-032f-4cea-8e75-0849878a36bc
6353560703ANDALake Erie Medical Dba Quality Care Products Llc1991-08-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910385ANDA08108012437969-1422-4aca-92b3-f189345a1ea1
7422540228ANDARebel Distributors Corp2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA04020116796dd0-8d42-4e0e-8a9f-2b3b8834ed84
8425490516ANDAStat Rx Usa Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA040201c8be6c8d-7c55-459b-bc16-7651c2fd6e27
9499990053ANDALake Erie Medical Dba Quality Care Products Llc2011-11-03ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA040201d94dc983-98a9-47e1-9336-95c9142ca497
10521250314ANDARemedyrepack Inc.2013-05-13ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033882ANDA0401443791531f-b843-4a08-a9cb-b0422b763d58
11548683038ANDAPhysicians Total Care, Inc.1994-01-132014-02-15ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA040201ab52a549-8ecc-441a-8733-0fda146e9932
12551547201LortabANDACardinal Health2011-01-13ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740907ANDA089699e756cbcd-a907-4116-b148-ccd3158ba261
13551547272ANDACardinal Health2010-04-222017-07-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA0402017742d54e-89f7-4911-92d6-ca883aa8269a
14604290510ANDAGolden State Medical Supply, Inc.2011-05-192018-09-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA0402018a9414c0-93cb-41a3-984e-e2e3708bd499
15637390141ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2005-03-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033882ANDA0401441cfb6720-c52d-4d84-b4a5-b63570b239bd
16638740295ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033882ANDA040144047af99e-1c90-4de3-9116-b29ac4cd85d3
17650840283LortabANDARxpak Division Of Mckesson Corporation2002-02-28ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET504740907ANDA0896993577d0de-010b-4266-9b6f-806bbddbbde9
18663360012ANDADispensing Solutions, Inc.1996-02-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033882ANDA040144f652a141-d29b-4f59-94fa-2b544084c13f
19672960492ANDARedpharm Drug Inc.2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460112ANDA040748a400434e-0e3d-49e3-ae12-9fda36380afe
20672960643ANDARedpharm Drug Inc.1996-02-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033882ANDA0401449b14cb88-ea9c-4666-8d91-dbab2e183199
21675440024ANDAAphena Pharma Solutions - Tennessee, Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA04020107b3ba11-6c4e-4fda-b322-cfbfd9f81021
22683870230ANDAKeltman Pharmaceuticals Inc.2010-07-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910385ANDA0896990af451fc-67e6-454b-88e7-ab5746f6dbb5
23762370183ANDAMckesson Contract Packaging2011-10-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060358ANDA040201a6b39b0c-3fb5-461c-aeae-3653cea7b121

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004060361ANDAMallinckrodt, Inc.2010-04-222016-08-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04008473c1059b-0c7d-42ef-9827-f018858fc447
2126340256ANDAApotheca, Inc2009-03-202013-12-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460114ANDA040757fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e
3165900120ANDAStat Rx Usa Llc1995-09-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910503ANDA040094598d6c89-e2e4-466d-82c1-5953b14250d7
4216950274ANDARebel Distributors Corp2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460114ANDA040757ee3bc2b6-76b1-486d-ab17-62222b24573f
5422540244ANDARebel Distributors Corp2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060361ANDA04008416796dd0-8d42-4e0e-8a9f-2b3b8834ed84
6433530187ANDAAphena Pharma Solutions - Tennessee, Llc1996-02-222013-12-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033885ANDA040143d22a77c7-7abe-492c-894a-954fb4947fd7
7499990277ANDALake Erie Medical Dba Quality Care Products Llc2011-02-05ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060361ANDA040084d4aa02ce-82ae-47b5-bd20-71d77293fec3
8550452386ANDADispensing Solutions, Inc.1996-02-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033885ANDA0401434c4f0d04-a4e3-46ce-bc19-e9a833719b87
9551547301LorcetANDACardinal Health1992-05-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET007856350ANDA081223353c0141-8e9a-45b6-b8ad-3113db8c0d2e
10638740861ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033885ANDA040143047af99e-1c90-4de3-9116-b29ac4cd85d3
11650840266LorcetANDARxpak Division Of Mckesson Corporation2001-12-21ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET007856350ANDA081223604bbd25-33d0-4f90-b304-ed80702c3c37
12663360406ANDADispensing Solutions, Inc.1996-02-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033885ANDA040143da8c53be-8bf0-4d2c-bec1-2ff3c186a7e6
13672960719ANDARedpharm Drug Inc.1996-02-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033885ANDA0401439ce3b2bf-fa69-4940-95af-960cc0bb8320
14675440026ANDAAphena Pharma Solutions - Tennessee, Inc.2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060361ANDA04008407b3ba11-6c4e-4fda-b322-cfbfd9f81021
15762370179ANDAMckesson Contract Packaging2011-11-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060361ANDA040084a6b39b0c-3fb5-461c-aeae-3653cea7b121

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004060359ANDAMallinckrodt, Inc.2010-04-222016-06-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA08972573c1059b-0c7d-42ef-9827-f018858fc447
2126340166ANDAApotheca, Inc2009-09-24ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910502ANDA040094d29d8c9c-c3be-4428-99e5-017d030a46f2
3165900116ANDAStat Rx Usa Llc1995-09-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910502ANDA040094598d6c89-e2e4-466d-82c1-5953b14250d7
4216950436ANDARebel Distributors Corp2009-06-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460113ANDA0407541b0f1d32-7737-4ee2-b1db-02ccaea2c577
5458650412ANDAMedsource Pharmaceuticals2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460113ANDA040754f83f57cd-0257-4745-8ee0-21dc6dc05063
6548683585ANDAPhysicians Total Care, Inc.2004-08-122014-02-15ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060359ANDA089725ab52a549-8ecc-441a-8733-0fda146e9932
7551547302LorcetANDACardinal Health1988-06-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET007851122ANDA089689fa700965-112d-4907-9e08-8c57f5c90b4a
8650840267LorcetANDARxpak Division Of Mckesson Corporation2001-12-21ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET007851122ANDA089689f8399d7a-7e4c-4f2c-ae7f-60ef0ae0c7f4
9663360748ANDADispensing Solutions, Inc.1997-04-14ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033884ANDA040155fd075b8a-4ee8-45cd-bdef-d75cf3480e06

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004060362ANDAMallinckrodt, Inc.2010-04-222016-06-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04008473c1059b-0c7d-42ef-9827-f018858fc447
2165900875ANDAStat Rx Usa Llc2000-05-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033886ANDA040358f2f95758-4a60-4394-933c-52c7c648a24f
3216950508ANDARebel Distributors Corp2003-05-28ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET620370567ANDA040495c326aa5c-cf35-4c87-9ed2-502bf9babb90
4551541607VicodinANDACardinal Health1996-09-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET000742274ANDA040117496ed99b-7bce-4ade-b7c3-6c59feebce6f
5620370567ANDAActavis Pharma, Inc.2003-05-28ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040495c790e193-7f5f-4fd0-90ca-36b65f7f66e6
6636294355ANDABryant Ranch Prepack2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060362ANDA040084ed0da522-7a33-bec3-2f1e-a0ad4b000cae
7638740279ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033886ANDA040358047af99e-1c90-4de3-9116-b29ac4cd85d3

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004060364ANDAMallinckrodt, Inc.2010-04-222015-01-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04046873c1059b-0c7d-42ef-9827-f018858fc447
2525440163MaxidoneANDAActavis Pharma, Inc.2013-03-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04009469851af3-f30b-4b11-b171-564ce6ab0f65
3525440634MaxidoneANDAActavis Pharma, Inc.1999-03-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA040094a2617a15-b333-4ffc-98eb-36d8721aa0d6

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004060360ANDAMallinckrodt, Inc.2010-04-222016-06-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLETANDA04008473c1059b-0c7d-42ef-9827-f018858fc447
2126340849ANDAApotheca, Inc2007-04-23ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910387ANDA081083d29d8c9c-c3be-4428-99e5-017d030a46f2
3165900117ANDAStat Rx Usa Llc1991-08-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910387ANDA081083598d6c89-e2e4-466d-82c1-5953b14250d7
4216950271ANDARebel Distributors Corp2010-02-10ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460118ANDA040769f6d5fe9a-032f-4cea-8e75-0849878a36bc
5422540223ANDARebel Distributors Corp2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060360ANDA04008416796dd0-8d42-4e0e-8a9f-2b3b8834ed84
6425490586ANDAStat Rx Usa Llc2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460118ANDA040769aba6b073-c986-4e06-8b6b-ab0d57755f70
7433530017ANDAAphena Pharma Solutions - Tennessee, Llc1996-04-122013-12-31ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033883ANDA040157d22a77c7-7abe-492c-894a-954fb4947fd7
8433530422ANDAAphena Pharma Solutions - Tennessee, Llc2010-04-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060360ANDA040084b6c6ee17-6414-4974-8915-418b16f64545
9499990052ANDALake Erie Medical Dba Quality Care Products Llc2010-08-23, 2010-09-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060360ANDA040468102c41c5-4519-4fbd-bcd3-f3c6d7c9547d, cc6d4b64-6ccc-4a2b-b4e0-d553440e85aa
10504363915ANDAUnit Dose Services1996-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033883ANDA0401575faf4070-81de-422a-b9f8-e018406bd6d8
11548682281ANDAPhysicians Total Care, Inc.1995-04-242014-02-15ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060360ANDA040084ab52a549-8ecc-441a-8733-0fda146e9932
12551541604VicodinANDACardinal Health2010-05-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET000741973ANDA0897362941e685-d8fd-40bc-8d1a-393facbd3826
13637390131ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2004-12-22ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033883ANDA0401571cfb6720-c52d-4d84-b4a5-b63570b239bd
14638740230ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033883ANDA040157047af99e-1c90-4de3-9116-b29ac4cd85d3
15663360106ANDADispensing Solutions, Inc.1996-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033883ANDA040157eec087de-b846-4c18-9ae6-2c2b6dc85fb9
16672960016ANDARedpharm Drug Inc.2011-03-03ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET005910387ANDA081083b165dffd-1550-4d8d-a8ea-fe83512c34e6
17672960377ANDARedpharm Drug Inc.2010-02-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET537460118ANDA0407694d756f4d-5e60-4833-8b48-1d09d1bbd407
18672960642ANDARedpharm Drug Inc.1996-04-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET006033883ANDA0401576a54ccf9-0579-40cb-97b0-fd6bb99ebb0f
19762370185ANDAMckesson Contract Packaging2011-11-04ACETAMINOPHEN, HYDROCODONE BITARTRATEORALTABLET004060360ANDA040084a6b39b0c-3fb5-461c-aeae-3653cea7b121

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA040084HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMALLINCKRODT CHEMICAL INC1995-06-01ANDA040084_001, ANDA040084_002, ANDA040084_003, ANDA040084_004Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
2ANDA040094HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1995-09-29ANDA040094_001, ANDA040094_002, ANDA040094_003, ANDA040094_004Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
3ANDA040099NORCOWATSON LABORATORIES1997-06-25ANDA040099_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
4ANDA040100LORTABTrueUCB INC1996-01-26ANDA040100_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
5ANDA040117VICODIN HPTrueABBVIE INC1996-09-23ANDA040117_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
6ANDA040122HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1996-03-04ANDA040122_001, ANDA040122_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
7ANDA040123HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1996-03-04ANDA040123_001, ANDA040123_002, ANDA040123_003, ANDA040123_004Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
8ANDA040134HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUCB INC1996-11-21ANDA040134_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
9ANDA040143HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-02-22ANDA040143_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
10ANDA040144HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-02-22ANDA040144_001, ANDA040144_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
11ANDA040148HYDROCODONE BITARTRATE AND ACETAMINOPHENACTAVIS LABORATORIES FL INC1997-02-14ANDA040148_001, ANDA040148_002, ANDA040148_003, ANDA040148_004, ANDA040148_005Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
12ANDA040149HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueSANDOZ INC1997-01-27ANDA040149_001, ANDA040149_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
13ANDA040155HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1997-04-14ANDA040155_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
14ANDA040157HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-04-12ANDA040157_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
15ANDA040201HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMALLINCKRODT CHEMICAL INC1998-02-27ANDA040201_001, ANDA040201_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
16ANDA040210HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUCB INC1997-08-13ANDA040210_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
17ANDA040236HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1997-09-25ANDA040236_001, ANDA040236_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
18ANDA040240HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1997-11-26ANDA040240_001, ANDA040240_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
19ANDA040248HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC2000-04-28ANDA040248_001, ANDA040248_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
20ANDA040280HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS LLC1998-09-30ANDA040280_001, ANDA040280_002, ANDA040280_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
21ANDA040281HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS LLC1998-09-30ANDA040281_001, ANDA040281_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
22ANDA040288ZYDONETrueVINTAGE PHARMACEUTICALS LLC1998-11-27ANDA040288_001, ANDA040288_002, ANDA040288_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
23ANDA040307HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-07-26ANDA040307_001, ANDA040307_002, ANDA040307_003, ANDA040307_004Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
24ANDA040308HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-07-26ANDA040308_001, ANDA040308_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
25ANDA040309HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-07-26ANDA040309_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
26ANDA040355HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS INC2000-05-31ANDA040355_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
27ANDA040356HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC2000-05-31ANDA040356_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
28ANDA040358HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC2000-05-31ANDA040358_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
29ANDA040400HYDROCODONE BITARTRATE AND ACETAMINOPHENMALLINCKRODT INC2000-07-26ANDA040400_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
30ANDA040405ANEXSIA 7.5/325MALLINCKRODT INC2000-09-08ANDA040405_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
31ANDA040409ANEXSIA 5/325MALLINCKRODT INC2000-10-20ANDA040409_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
32ANDA040432HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2003-01-22ANDA040432_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
33ANDA040464HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-10-23ANDA040464_001, ANDA040464_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
34ANDA040468ANEXSIATrueMALLINCKRODT INC2002-10-31ANDA040468_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
35ANDA040469HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-10-25ANDA040469_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
36ANDA040473HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-11-06ANDA040473_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
37ANDA040474HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2003-01-02ANDA040474_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
38ANDA040476HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-10-23ANDA040476_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
39ANDA040477HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-11-06ANDA040477_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
40ANDA040478HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-11-08ANDA040478_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
41ANDA040490HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2003-05-21ANDA040490_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
42ANDA040493HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2003-05-28ANDA040493_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
43ANDA040494HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2003-05-28ANDA040494_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
44ANDA040495HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2003-05-28ANDA040495_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
45ANDA040556HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2004-06-23ANDA040556_001, ANDA040556_002Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
46ANDA040655HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS INC2006-01-19ANDA040655_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
47ANDA040656HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS INC2006-01-19ANDA040656_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
48ANDA040658HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2006-01-19ANDA040658_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
49ANDA040729HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040729_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
50ANDA040736HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040736_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
51ANDA040746HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040746_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
52ANDA040748HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040748_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
53ANDA040754HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040754_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
54ANDA040757HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040757_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
55ANDA040769HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-28ANDA040769_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
56ANDA040813HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2007-02-23ANDA040813_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
57ANDA040822HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueRANBAXY LABORATORIES LTD2007-08-16ANDA040822_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
58ANDA040824HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueRANBAXY LABORATORIES INC2007-08-16ANDA040824_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
59ANDA040825HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueRANBAXY INC2007-08-16ANDA040825_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
60ANDA040826HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueSUN PHARMACEUTICAL INDUSTRIES LTD2007-08-16ANDA040826_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
61ANDA040846HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2010-06-09ANDA040846_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
62ANDA040849HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC2010-06-09ANDA040849_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
63ANDA076023HYDROCODONE BITARTRATE AND IBUPROFENTEVA PHARMACEUTICALS USA INC2003-04-11ANDA076023_001Hydrocodone / Ibuprofen Oral Tablet
64ANDA076604HYDROCODONE BITARTRATE AND IBUPROFENACTAVIS LABORATORIES FL INC2003-12-31ANDA076604_001Hydrocodone / Ibuprofen Oral Tablet
65ANDA076642HYDROCODONE BITARTRATE AND IBUPROFENAMNEAL PHARMACEUTICALS NY LLC2004-03-18ANDA076642_001, ANDA076642_002, ANDA076642_003, ANDA076642_004Hydrocodone / Ibuprofen Oral Tablet
66ANDA077454HYDROCODONE BITARTRATE AND IBUPROFENACTAVIS LABORATORIES FL INC2010-06-23ANDA077454_001Hydrocodone / Ibuprofen Oral Tablet
67ANDA077723HYDROCODONE BITARTRATE AND IBUPROFENVINTAGE PHARMACEUTICALS INC2006-11-06ANDA077723_001, ANDA077723_002Hydrocodone / Ibuprofen Oral Tablet
68ANDA077727HYDROCODONE BITARTRATE AND IBUPROFENVINTAGE PHARMACEUTICALS INC2006-11-06ANDA077727_001Hydrocodone / Ibuprofen Oral Tablet
69ANDA081079HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1991-08-30ANDA081079_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
70ANDA081080HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1991-08-30ANDA081080_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
71ANDA081083HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1991-08-30ANDA081083_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
72ANDA081223HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-05-29ANDA081223_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
73ANDA085667VICODINTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA085667_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
74ANDA087677HY-PHENTrueBF ASCHER AND CO INC1982-05-03ANDA087677_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
75ANDA087722LORTABTrueUCB INC1982-07-09ANDA087722_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
76ANDA087757CO-GESICTrueUCB INC1982-05-03ANDA087757_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
77ANDA087809DURADYNE DHCTrueFOREST PHARMACEUTICALS INC1983-03-17ANDA087809_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
78ANDA088058VICODINTrueABBVIE INC1983-01-07ANDA088058_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
79ANDA088577HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC1984-12-21ANDA088577_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
80ANDA088871NORCETTrueABANA PHARMACEUTICALS INC1986-05-15ANDA088871_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
81ANDA089160ANEXSIATrueMALLINCKRODT CHEMICAL INC1987-04-23ANDA089160_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
82ANDA089271HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1986-07-16ANDA089271_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
83ANDA089290HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUSL PHARMA INC1987-05-29ANDA089290_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
84ANDA089291HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUSL PHARMA INC1987-05-29ANDA089291_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
85ANDA089385TYCOLETTrueORTHO MCNEIL PHARMACEUTICAL INC1986-08-27ANDA089385_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
86ANDA089554HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueHALSEY DRUG CO INC1987-06-12ANDA089554_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
87ANDA089689HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1988-06-29ANDA089689_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
88ANDA089696HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueIVAX PHARMACEUTICALS INC1988-04-21ANDA089696_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
89ANDA089697HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-01-28ANDA089697_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
90ANDA089698HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1989-08-25ANDA089698_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
91ANDA089699HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1989-08-25ANDA089699_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
92ANDA089725ANEXSIA 7.5/650TrueMALLINCKRODT CHEMICAL INC1987-09-30ANDA089725_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
93ANDA089736VICODIN ESTrueABBVIE INC1988-12-09ANDA089736_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
94ANDA089831HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1988-09-07ANDA089831_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
95ANDA089883HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1988-12-01ANDA089883_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
96ANDA089971HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1988-12-02ANDA089971_001Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
97ANDA090118HYDROCODONE BITARTRATE AND ACETAMINOPHENSUN PHARMACEUTICAL INDUSTRIES INC2008-12-23ANDA090118_001, ANDA090118_002, ANDA090118_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
98ANDA090265HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueCARACO PHARMACEUTICAL LABORATORIES LTD2008-12-23ANDA090265_001, ANDA090265_002, ANDA090265_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
99ANDA090380HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueCARACO PHARMACEUTICAL LABORATORIES LTD2008-12-23ANDA090380_001, ANDA090380_002, ANDA090380_003, ANDA090380_004Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
100ANDA090415HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS2011-01-24ANDA090415_001, ANDA090415_002, ANDA090415_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
101ANDA091633HYDROCODONE BITARTRATE AND IBUPROFENSUN PHARMACEUTICAL INDUSTRIES INC2013-05-28ANDA091633_001, ANDA091633_002, ANDA091633_003, ANDA091633_004Hydrocodone / Ibuprofen Oral Tablet
102ANDA201013HYDROCODONE BITARTRATE AND ACETAMINOPHENAUROLIFE PHARMA LLC2012-04-11ANDA201013_001, ANDA201013_002, ANDA201013_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
103ANDA202214HYDROCODONE BITARTRATE AND ACETAMINOPHENTRIS PHARMA INC2013-03-27ANDA202214_001, ANDA202214_002, ANDA202214_003Acetaminophen / Codeine Oral Solution
Alprazolam Oral Tablet
104NDA020716VICOPROFENABBVIE INC1997-09-23p6348216
p6599531
NDA020716_001Hydrocodone / Ibuprofen Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040084_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1995-06-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN
2ANDA040084_002discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1995-06-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN
3ANDA040084_003discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-07-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
4ANDA040084_004discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-10-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
5ANDA040094_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1995-09-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
6ANDA040094_002discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1995-09-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
7ANDA040094_003discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (660MG)ORALTABLETFalse2000-08-08HYDROCODONE BITARTRATE AND ACETAMINOPHEN
8ANDA040094_004discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1999-03-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
9ANDA040099_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETTrueAA1997-06-25NORCO
10ANDA040100_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-01-26LORTAB
11ANDA040117_001discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-09-23VICODIN HP
12ANDA040122_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
13ANDA040122_002discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
14ANDA040123_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
15ANDA040123_002discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
16ANDA040123_003discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
17ANDA040123_004discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
18ANDA040134_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1996-11-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
19ANDA040143_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-02-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
20ANDA040144_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1996-02-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
21ANDA040144_002discontinuedHYDROCODONE BITARTRATE (2.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1997-04-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
22ANDA040148_001RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETTrueAA1997-02-14HYDROCODONE BITARTRATE AND ACETAMINOPHEN
23ANDA040148_002discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1997-02-14HYDROCODONE BITARTRATE AND ACETAMINOPHEN
24ANDA040148_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETTrueAA2000-09-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN
25ANDA040148_004RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalseAA2014-07-07HYDROCODONE BITARTRATE AND ACETAMINOPHEN
26ANDA040148_005RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2014-07-07HYDROCODONE BITARTRATE AND ACETAMINOPHEN
27ANDA040149_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1997-01-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
28ANDA040149_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1997-01-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
29ANDA040155_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1997-04-14HYDROCODONE BITARTRATE AND ACETAMINOPHEN
30ANDA040157_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1996-04-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN
31ANDA040201_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1998-02-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
32ANDA040201_002discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1998-02-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
33ANDA040210_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1997-08-13HYDROCODONE BITARTRATE AND ACETAMINOPHEN
34ANDA040236_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1997-09-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
35ANDA040236_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1997-09-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
36ANDA040240_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1997-11-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
37ANDA040240_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1997-11-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
38ANDA040248_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalse2000-04-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
39ANDA040248_002discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2000-04-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
40ANDA040280_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
41ANDA040280_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
42ANDA040280_003discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
43ANDA040281_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
44ANDA040281_002discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
45ANDA040288_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (400MG)ORALTABLETFalse1998-11-27ZYDONE
46ANDA040288_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (400MG)ORALTABLETFalse1998-11-27ZYDONE
47ANDA040288_003discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (400MG)ORALTABLETFalse1998-11-27ZYDONE
48ANDA040307_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
49ANDA040307_002discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
50ANDA040307_003discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
51ANDA040307_004discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
52ANDA040308_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
53ANDA040308_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
54ANDA040309_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
55ANDA040355_001RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2000-05-31HYDROCODONE BITARTRATE AND ACETAMINOPHEN
56ANDA040356_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2000-05-31HYDROCODONE BITARTRATE AND ACETAMINOPHEN
57ANDA040358_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (660MG)ORALTABLETFalse2000-05-31HYDROCODONE BITARTRATE AND ACETAMINOPHEN
58ANDA040400_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
59ANDA040405_001RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2000-09-08ANEXSIA 7.5/325
60ANDA040409_001RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2000-10-20ANEXSIA 5/325
61ANDA040432_001RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2003-01-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
62ANDA040464_001discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2002-10-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
63ANDA040464_002discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2002-10-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
64ANDA040468_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2002-10-31ANEXSIA
65ANDA040469_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2002-10-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
66ANDA040473_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2002-11-06HYDROCODONE BITARTRATE AND ACETAMINOPHEN
67ANDA040474_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2003-01-02HYDROCODONE BITARTRATE AND ACETAMINOPHEN
68ANDA040476_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2002-10-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
69ANDA040477_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2002-11-06HYDROCODONE BITARTRATE AND ACETAMINOPHEN
70ANDA040478_001discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2002-11-08HYDROCODONE BITARTRATE AND ACETAMINOPHEN
71ANDA040490_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2003-05-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
72ANDA040493_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2003-05-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
73ANDA040494_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2003-05-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
74ANDA040495_001discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2003-05-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
75ANDA040556_001RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETTrueAA2004-06-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
76ANDA040556_002RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETTrueAA2006-03-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
77ANDA040655_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2006-01-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
78ANDA040656_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAA2006-01-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
79ANDA040658_001RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETTrueAA2006-01-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
80ANDA040729_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
81ANDA040736_001RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
82ANDA040746_001RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
83ANDA040748_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
84ANDA040754_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
85ANDA040757_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
86ANDA040769_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2006-08-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
87ANDA040813_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2007-02-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
88ANDA040822_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
89ANDA040824_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
90ANDA040825_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
91ANDA040826_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
92ANDA040846_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETTrueAA2010-06-09HYDROCODONE BITARTRATE AND ACETAMINOPHEN
93ANDA040849_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2010-06-09HYDROCODONE BITARTRATE AND ACETAMINOPHEN
94ANDA076023_001RXHYDROCODONE BITARTRATE (7.5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2003-04-11HYDROCODONE BITARTRATE AND IBUPROFEN
95ANDA076604_001RXHYDROCODONE BITARTRATE (7.5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2003-12-31HYDROCODONE BITARTRATE AND IBUPROFEN
96ANDA076642_001RXIBUPROFEN (200MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAB2004-10-12HYDROCODONE BITARTRATE AND IBUPROFEN
97ANDA076642_002RXHYDROCODONE BITARTRATE (5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2004-03-18HYDROCODONE BITARTRATE AND IBUPROFEN
98ANDA076642_003RXHYDROCODONE BITARTRATE (2.5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2007-10-19HYDROCODONE BITARTRATE AND IBUPROFEN
99ANDA076642_004RXIBUPROFEN (200MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAB2007-10-19HYDROCODONE BITARTRATE AND IBUPROFEN
100ANDA077454_001RXHYDROCODONE BITARTRATE (5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2010-06-23HYDROCODONE BITARTRATE AND IBUPROFEN
101ANDA077723_001RXHYDROCODONE BITARTRATE (7.5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2006-11-06HYDROCODONE BITARTRATE AND IBUPROFEN
102ANDA077723_002RXIBUPROFEN (200MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAB2006-11-06HYDROCODONE BITARTRATE AND IBUPROFEN
103ANDA077727_001RXHYDROCODONE BITARTRATE (5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2006-11-06HYDROCODONE BITARTRATE AND IBUPROFEN
104ANDA081079_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalse1991-08-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
105ANDA081080_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1991-08-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
106ANDA081083_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1991-08-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
107ANDA081223_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1992-05-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
108ANDA085667_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalseVICODIN
109ANDA087677_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1982-05-03HY-PHEN
110ANDA087722_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1982-07-09LORTAB
111ANDA087757_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1982-05-03CO-GESIC
112ANDA087809_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1983-03-17DURADYNE DHC
113ANDA088058_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1983-01-07VICODIN
114ANDA088577_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1984-12-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
115ANDA088871_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1986-05-15NORCET
116ANDA089160_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1987-04-23ANEXSIA
117ANDA089271_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1986-07-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
118ANDA089290_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1987-05-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
119ANDA089291_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1987-05-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
120ANDA089385_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1986-08-27TYCOLET
121ANDA089554_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1987-06-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN
122ANDA089689_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1988-06-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
123ANDA089696_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1988-04-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
124ANDA089697_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1992-01-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
125ANDA089698_001discontinuedHYDROCODONE BITARTRATE (2.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1989-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
126ANDA089699_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1989-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
127ANDA089725_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1987-09-30ANEXSIA 7.5/650
128ANDA089736_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1988-12-09VICODIN ES
129ANDA089831_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1988-09-07HYDROCODONE BITARTRATE AND ACETAMINOPHEN
130ANDA089883_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1988-12-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN
131ANDA089971_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1988-12-02HYDROCODONE BITARTRATE AND ACETAMINOPHEN
132ANDA090118_001RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
133ANDA090118_002RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAA2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
134ANDA090118_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
135ANDA090265_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
136ANDA090265_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
137ANDA090265_003discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
138ANDA090380_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
139ANDA090380_002discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
140ANDA090380_003discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
141ANDA090380_004discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
142ANDA090415_001RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2011-01-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
143ANDA090415_002RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (300MG)ORALTABLETFalseAA2011-01-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
144ANDA090415_003RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (300MG)ORALTABLETFalseAA2011-01-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
145ANDA091633_001RXHYDROCODONE BITARTRATE (2.5MG), IBUPROFEN (200MG)ORALTABLETFalseAB2013-05-28HYDROCODONE BITARTRATE AND IBUPROFEN
146ANDA091633_002RXIBUPROFEN (200MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAB2013-05-28HYDROCODONE BITARTRATE AND IBUPROFEN
147ANDA091633_003RXIBUPROFEN (200MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAB2013-05-28HYDROCODONE BITARTRATE AND IBUPROFEN
148ANDA091633_004RXHYDROCODONE BITARTRATE (10MG), IBUPROFEN (200MG)ORALTABLETFalseAB2013-05-28HYDROCODONE BITARTRATE AND IBUPROFEN
149ANDA201013_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2012-04-11HYDROCODONE BITARTRATE AND ACETAMINOPHEN
150ANDA201013_002RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAA2012-04-11HYDROCODONE BITARTRATE AND ACETAMINOPHEN
151ANDA201013_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2012-04-11HYDROCODONE BITARTRATE AND ACETAMINOPHEN
152ANDA202214_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2013-03-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
153ANDA202214_002RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2013-03-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
154ANDA202214_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2013-03-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
155NDA020716_001RXIBUPROFEN (200MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETTrueAB1997-09-23VICOPROFEN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6348216 (view patent)2017-06-10NDA020716Hydrocodone / Ibuprofen Oral Tablet
2p6599531 (view patent)2017-06-10NDA020716Hydrocodone / Ibuprofen Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10045ec13-789a-40a1-ac1f-8c29049cfd13 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-04-082663360408
200eff641-4b66-4bfc-9310-5a76c257e007 (view SPL)Hydrocodone Bitartrate & AcetaminophenprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-06-093672960804
300f1e7e6-4f94-4bf4-a726-0b4ffbf6d1b1 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-10-091002636295432
400fda976-83fd-4b58-8ef7-1bf04e9c5a00 (view SPL)Hydrocodone Bitartrate and AcetaminophenTablets USP 5 mg/325 mgC-IIRx only Rev. 08/2014prescriptionHuman PrescriptionMajor2015-02-051009046419
5016df82c-a0a5-4f3b-bf73-f7e28f984c95 (view SPL)Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx OnlyprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2014-12-1710576640126, 576640170, 576640176
6029f39ed-ec6f-4fdc-bc0d-abfb6784cc91 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950579
703aea0d1-c808-40ae-9605-166733202166 (view SPL)Hydrocodone Bitartrateand AcetaminophenTablets USP2.5 mg/325 mgRx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-262332610881
804562feb-471d-4cae-832a-47eb31603b30 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx onlyprescriptionHuman PrescriptionMylan Institutional Inc.2015-02-0617510790777, 510790778, 510790779
9047af99e-1c90-4de3-9116-b29ac4cd85d3 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionAltura Pharmaceuticals, Inc.relabel, repack2010-04-271638740203, 638740230, 638740279, 638740293, 638740295, 638740834, 638740861
1006cd8ce6-8416-4747-b563-d88814539e12 (view SPL)Hydrocodone Bitartrateand AcetaminophenTablets USP2.5 mg/325 mgRx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-10-031000636295428
1106fc5b52-05dc-4c97-82a1-47b7ec2e3ee7 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-035551541183
1207b3ba11-6c4e-4fda-b322-cfbfd9f81021 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIIprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2013-05-011675440023, 675440024, 675440025, 675440026, 675440670
1308ff26ca-bbc1-4d53-a4d3-865f810cfb69 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-04-014545695240, 545695481, 545696027
140af451fc-67e6-454b-88e7-ab5746f6dbb5 (view SPL)hydrocodone bitartrate and acetaminophen tabletprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.relabel, repack2010-12-103683870230
150b195eb3-b51f-41b1-b869-29c1e7531457 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CII 7.5 mg/325 mg Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-10-011002636295436
160b212d93-8c64-400f-b8cd-242731f2252f (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx onlyprescriptionHuman PrescriptionSt Marys Medical Park PharmacyMANUFACTURE, relabel, repack2014-10-301607600032, 607600202
170b32a79b-ab42-4020-9c13-064284d95258 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-06-191516550900
180baf67c2-c1ef-4b6d-9498-62353e3bcd7a (view SPL)Hydrocodone Bitartrate & Acetaminophen TabletsprescriptionHuman PrescriptionRedpharm Drug Inc.2011-06-102672960589
190e7494b0-c061-49e8-bb02-3fd3bc960740 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-203422540079, 422540100
20102c41c5-4519-4fbd-bcd3-f3c6d7c9547d (view SPL)Hydrocodone Bitartrate and APAP 7.5 mg 750 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-05-313837499990052
21107033c5-679b-487c-aa33-49e8c35c6419 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx onlySeptember 2014prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-09-231637390704
221123ebe3-a565-4edb-958c-a3ccbdc547f1 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-04-012545698314
2312437969-1422-4aca-92b3-f189345a1ea1 (view SPL)Hydrocodone Bitartrate and APAP Tablets multi strengths-ANDAsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-07-093908353560703
241669c4be-67c8-4e24-a3c9-6f5dff3dea3e (view SPL)Hydrocodone Bitartrate and Acetaminophen Tablets, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2015-08-036353560795, 353560796, 353560797
2516796dd0-8d42-4e0e-8a9f-2b3b8834ed84 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIIprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-05-221422540223, 422540228, 422540244
261ac64001-75dd-4fba-9a89-9969364e5c9a (view SPL)HYDROCODONE BITARTRATEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-033619190118
271b0f1d32-7737-4ee2-b1db-02ccaea2c577 (view SPL)Hydrocodone-APAP-75650prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-302216950436
281b613496-07ab-4e62-9e80-1dcebea58ed6 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2014-10-161762370336, 762370400, 762370515
291b733f85-dafb-4242-be8a-65540d956380 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-08-192663360442
301bf4d591-b3c6-42c6-b038-ef1f52cfdf68 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-09-122687889250
311c6a1c66-8225-473b-bc48-ab11940ac03f (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USPCIIIprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-272242360068
321c7ff5b9-6698-4e8c-9060-2abcd3fb0dcf (view SPL)Norco (hydrocodone bitartrate and acetaminophen) 10mg/325 mgprescriptionHuman PrescriptionCardinal HealthREPACK2011-08-171551541150
331cfb6720-c52d-4d84-b4a5-b63570b239bd (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2011-11-011637390131, 637390141, 637390532
341dce86ff-e194-418f-976f-4dd13c37174a (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHENprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-033619190114
351e171e42-6083-4873-e054-00144ff88e88 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx onlyprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-08-241458650419, 458650605
361ea23e17-2399-4656-b055-2ad9cbdb6388 (view SPL)Hydrocodone Bitartrate and Acetaminophen Tablets USP CIII Rx onlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-10-174680840100
3721ff13de-6633-4dd3-728e-dc21e574ea7b (view SPL)VICODIN VICODIN ES VICODIN HP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLETS, USPRx only CS-IIprescriptionHuman PrescriptionAbbvie Inc.2014-08-2542000743041, 000743043, 000743054
38221c6c53-35b8-4bd7-adfc-f8200b9f49c1 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-04-235529590737
3922cb6a7b-9d83-4d10-aaa5-cd950acc20a7 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-03-104493490671
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238f83f57cd-0257-4745-8ee0-21dc6dc05063 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USPprescriptionHuman PrescriptionMedsource Pharmaceuticals2012-07-243458650412
239fa2a09a8-7835-4261-a9b1-b35adab27de7 (view SPL)HYDROCODONE BITARTRATEprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-10-272619190494
240fa32969f-7210-47ec-bbd1-f62bea8989a7 (view SPL)Hydrocodone Bitartrate and AcetaminophenTablets USP 5 mg/325 mgC-IIRx only Rev. 08/2014prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2014-08-0110005913202
241fa700965-112d-4907-9e08-8c57f5c90b4a (view SPL)Lorcet Plus (hydrocodone bitartrate and acetaminophen) 7.5 mg/650 mgprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-161551547302
242facf04ae-3246-4c27-9ae0-d877d6573d7e (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIIprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2014-12-313604290574
243fb68d701-a7c7-4817-8c92-b1a7e8a4282b (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIIprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-05-145604290572, 604290573
244fc3c3d40-69ba-4273-b7a1-cf715b68478d (view SPL)Hydrocodone Bitartrate and Acetaminophen Tablets USP CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-182680840884
245fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSIIprescriptionHuman PrescriptionApotheca, Increpack2010-04-134126340144, 126340256, 126340978
246fcff467e-ddcb-48d1-ac8b-a8e4435eebb2 (view SPL)prescriptionHuman PrescriptionPharmpak, Inc.relabel, repack2015-01-152543480066
247fd075b8a-4ee8-45cd-bdef-d75cf3480e06 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-111663360748
248fdd25fee-0a2b-1297-b87b-07c47f09c8e2 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN, USP CIIprescriptionHuman PrescriptionAvpak2014-10-0612502680403, 502680408
249fe743045-6501-4d99-ae8d-7b0f3e27c656 (view SPL)Hydrocodone Bitartrate and Acetaminophen Tablets, USPCIIIprescriptionHuman PrescriptionApotheca, Increpack2014-01-081126340260

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII