Acetaminophen / Hydrocodone Oral Solution

Brand(s)
Hycet, Lortab, Zamicet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaceutical Associates, Inc. (2014-10-22)
Oldest Current Product
1994-08-16
License(s)
ANDA
RxNORM
ORAL SOLUTION\ACETAMINOPHEN:HYDROCODONE
FDAOB
ORAL\SOLUTION\ACETAMINOPHEN: HYDROCODONE BITARTRATE
SPL Active
ORAL\SOLUTION\ACETAMINOPHEN: HYDROCODONE BITARTRATE
ORAL\SYRUP\ACETAMINOPHEN: HYDROCODONE BITARTRATE
SPL Moiety
ORAL\SOLUTION\ACETAMINOPHEN: HYDROCODONE
ORAL\SYRUP\ACETAMINOPHEN: HYDROCODONE

product(s) by strength(s)

acetaminophen 20 mg/ml / hydrocodone bitartrate 0.667 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000959090LortabANDAEcr Pharmaceuticals2013-09-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSYRUPANDA04088155386fe7-990a-4596-a109-a6553a57bc7c
2174780450LortabANDAAkorn2015-03-17ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSYRUPANDA04088121def91d-b6e3-4dde-983c-6925aedf0df0
3466720645ANDAMikart, Inc.2010-02-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSYRUPANDA0408817da90197-5801-4855-956e-a9373b3dec8c

acetaminophen 21.7 mg/ml / hydrocodone bitartrate 0.5 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210772ANDAPharmaceutical Associates, Inc.2013-07-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA040838c29b97e9-8097-4d87-a420-ccf5aec8274a
2001214772ANDAPharmaceutical Associates, Inc.2013-07-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA040838c29b97e9-8097-4d87-a420-ccf5aec8274a
3007130703HycetANDAG&W Laboratories, Inc.2011-02-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA04048247df0152-b0a7-d03a-01e5-b9e22c3533c8
4007130704ANDAG&W Laboratories, Inc.2011-02-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA040482fab011c0-6924-653a-832f-c5a9261790e2
5466720642ANDAMikart, Inc.2003-09-25ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSYRUPANDA0404829cdd9d7e-f0b9-4d81-8f20-a16e687b479e
6643760640ANDABoca Pharmacal, Llc2011-07-27ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA0408947ce39f88-496d-490a-bab4-07d0b628ce65
7649500340ANDALehigh Valley Technologies, Inc.2014-04-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA200343d54ea700-4218-4645-a9de-353d384c171e
8666890023ANDAVistapharm Inc.2012-02-20ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA20034341ebe34d-567d-4fea-9fcb-c93e990a7861

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560640ANDAAtlantic Biologicals Corps2011-07-27ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION643760640ANDA04089421539e8e-a9b9-49ab-9134-c2cdc0a54321
2545696500ANDAA-S Medication Solutions Llc2013-07-29ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION001210772ANDA040838de3b340f-7b58-4026-84f0-a24214bf8c49
3548686437ANDAPhysicians Total Care, Inc.2014-09-12ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION643760640ANDA040894e1580b70-08ad-4167-95ed-aa556ea8553e
4551544058ANDACardinal Health2012-02-20ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION666890023ANDA2003430d41e820-f8d9-4ef3-b47f-08e2bc78191a
5680940714ANDAPrecision Dose Inc.2014-02-27ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION643760640ANDA0408941f91f8e2-c10e-43f9-9ac4-0781f197d184

acetaminophen 21.7 mg/ml / hydrocodone bitartrate 0.67 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001214771ANDAPharmaceutical Associates, Inc.2008-08-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA040834793d4b68-33f8-44e8-a437-dfb7b3371998
2004860771ZamicetANDABeach Products, Inc.2015-03-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA04083443c30b52-7bfb-4d0f-abcf-465c919a10bf
3004864771ZamicetANDABeach Products, Inc.2015-03-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA04083443c30b52-7bfb-4d0f-abcf-465c919a10bf

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001214655ANDAPharmaceutical Associates, Inc.2011-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTIONANDA0401823f3038e8-934a-4c5c-bd0a-f376ab97a934
2178561295ANDAAtlantic Biologicals Corps2003-10-30ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION006031295ANDA040520484a2b25-77aa-48d6-ac7f-2dcca0771505
3216950816ANDARebel Distributors Corp1998-03-13ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION001210655ANDA040182923abdb6-1ec5-415a-9269-67e16e8e1fff
4532170020ANDAAidarex Pharmaceuticals Llc2011-01-01ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION001210655ANDA040182dad13e49-e79b-4cd0-bfbf-04d5704c3be0
5548682908LortabANDAPhysicians Total Care, Inc.1994-08-16ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSYRUP504740909ANDA040520cba848e7-65fd-4b1a-ab56-50d865dcc251
6548684747ANDAPhysicians Total Care, Inc.2003-03-27ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION001210655ANDA040182f91a4c88-c083-45ab-8940-beaa9d9dcc24

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340615ANDAApotheca, Inc2013-06-18ACETAMINOPHEN, HYDROCODONE BITARTRATEORALSOLUTION001210655ANDA04018202610afb-bfad-47df-9913-cb2b12768f83

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040182HYDROCODONE BITARTRATE AND ACETAMINOPHENTruePHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1998-03-13ANDA040182_001
2ANDA040366HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueNESHER PHARMACEUTICALS USA LLC2002-01-23ANDA040366_001
3ANDA040418HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMALLINCKRODT INC2001-06-27ANDA040418_001
4ANDA040482HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2003-09-25ANDA040482_001
5ANDA040508HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMALLINCKRODT INC2003-08-29ANDA040508_001
6ANDA040520HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC2003-10-30ANDA040520_001
7ANDA040834HYDROCODONE BITARTRATE AND ACETAMINOPHENPHARMACEUTICAL ASSOC INC2008-04-18ANDA040834_001
8ANDA040838HYDROCODONE BITARTRATE AND ACETAMINOPHENPHARMACEUTICAL ASSOCIATES INC2013-05-10ANDA040838_001
9ANDA040881HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2010-02-25ANDA040881_001
10ANDA040894HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS2011-07-19ANDA040894_001
11ANDA081051HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-08-28ANDA081051_001
12ANDA081226HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-10-27ANDA081226_001
13ANDA089557HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-04-29ANDA089557_001
14ANDA200343HYDROCODONE BITARTRATE AND ACETAMINOPHENVISTAPHARM INC2012-01-25ANDA200343_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040182_001discontinuedHYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML)ORALSOLUTIONFalse1998-03-13HYDROCODONE BITARTRATE AND ACETAMINOPHEN
2ANDA040366_001discontinuedACETAMINOPHEN (500MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML)ORALSOLUTIONFalse2002-01-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
3ANDA040418_001discontinuedHYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML)ORALSOLUTIONFalse2001-06-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
4ANDA040482_001RXACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML)ORALSOLUTIONTrueAA2003-09-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
5ANDA040508_001discontinuedACETAMINOPHEN (500MG/15ML), HYDROCODONE BITARTRATE (10MG/15ML)ORALSOLUTIONFalse2003-08-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
6ANDA040520_001discontinuedHYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML)ORALSOLUTIONFalse2003-10-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
7ANDA040834_001RXACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (10MG/15ML)ORALSOLUTIONTrue2008-04-18HYDROCODONE BITARTRATE AND ACETAMINOPHEN
8ANDA040838_001RXACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML)ORALSOLUTIONFalseAA2013-05-10HYDROCODONE BITARTRATE AND ACETAMINOPHEN
9ANDA040881_001RXHYDROCODONE BITARTRATE (10MG/15ML), ACETAMINOPHEN (300MG/15ML)ORALSOLUTIONTrue2010-02-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
10ANDA040894_001RXACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML)ORALSOLUTIONFalseAA2011-07-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
11ANDA081051_001discontinuedHYDROCODONE BITARTRATE (7.5MG/15ML), ACETAMINOPHEN (500MG/15ML)ORALSOLUTIONFalse1992-08-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
12ANDA081226_001discontinuedHYDROCODONE BITARTRATE (5MG/15ML), ACETAMINOPHEN (500MG/15ML)ORALSOLUTIONFalse1992-10-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
13ANDA089557_001discontinuedHYDROCODONE BITARTRATE (5MG/15ML), ACETAMINOPHEN (500MG/15ML)ORALSOLUTIONFalse1992-04-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
14ANDA200343_001RXACETAMINOPHEN (325MG/15ML), HYDROCODONE BITARTRATE (7.5MG/15ML)ORALSOLUTIONFalseAA2012-01-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102610afb-bfad-47df-9913-cb2b12768f83 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN USP, ORAL SOLUTION CIIIprescriptionHuman PrescriptionApotheca, Increpack2013-09-261126340615
20d41e820-f8d9-4ef3-b47f-08e2bc78191a (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored) CIIIprescriptionHuman PrescriptionCardinal HealthREPACK2014-01-291551544058
31f91f8e2-c10e-43f9-9ac4-0781f197d184 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral SolutionprescriptionHuman PrescriptionPrecision Dose Inc.2014-12-242680940714
421539e8e-a9b9-49ab-9134-c2cdc0a54321 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL)prescriptionHuman PrescriptionAtlantic Biologicals Corpsrelabel, repack2015-07-134178560640
521def91d-b6e3-4dde-983c-6925aedf0df0 (view SPL)prescriptionHuman PrescriptionAkorn2015-03-171174780450
63f3038e8-934a-4c5c-bd0a-f376ab97a934 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 2.5 mg/167 mg per 5 mLprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2013-12-197001214655
741ebe34d-567d-4fea-9fcb-c93e990a7861 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored) CIIprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2014-09-254666890023
843c30b52-7bfb-4d0f-abcf-465c919a10bf (view SPL)Zamicet CII (hydrocodone bitartrate and acetaminophen oral solution) 10 mg/325 mg per 15 mLprescriptionHuman PrescriptionBeach Products, Inc.MANUFACTURE2015-03-201004860771, 004864771
947df0152-b0a7-d03a-01e5-b9e22c3533c8 (view SPL)Hycet CII hydrocodone bitartrate and acetaminophen oral solution7.5 mg/325 mg per 15 mL Rx onlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2014-09-154007130703
10484a2b25-77aa-48d6-ac7f-2dcca0771505 (view SPL)HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 mg/500 mg per 15 mLprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2012-07-313178561295
1155386fe7-990a-4596-a109-a6553a57bc7c (view SPL)prescriptionHuman PrescriptionEcr Pharmaceuticals2014-04-073000959090
12793d4b68-33f8-44e8-a437-dfb7b3371998 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 10 mg/325 mg per 15 mL CIIprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2014-10-226001214771
137ce39f88-496d-490a-bab4-07d0b628ce65 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL)prescriptionHuman PrescriptionBoca Pharmacal, Llc2015-06-175643760640
147da90197-5801-4855-956e-a9373b3dec8c (view SPL)prescriptionHuman PrescriptionMikart, Inc.2014-09-292466720645
15923abdb6-1ec5-415a-9269-67e16e8e1fff (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg per 15 mLprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-301216950816
169cdd9d7e-f0b9-4d81-8f20-a16e687b479e (view SPL)prescriptionHuman PrescriptionMikart, Inc.2014-09-294466720642
17c29b97e9-8097-4d87-a420-ccf5aec8274a (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mLprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2014-10-024001210772, 001214772
18cba848e7-65fd-4b1a-ab56-50d865dcc251 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-03-251548682908
19d54ea700-4218-4645-a9de-353d384c171e (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral SolutionprescriptionHuman PrescriptionLehigh Valley Technologies, Inc.2014-11-112649500340
20dad13e49-e79b-4cd0-bfbf-04d5704c3be0 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg per 15 mLprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-10-011532170020
21de3b340f-7b58-4026-84f0-a24214bf8c49 (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mLprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-06-121545696500
22e1580b70-08ad-4167-95ed-aa556ea8553e (view SPL)Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2014-10-232548686437
23f91a4c88-c083-45ab-8940-beaa9d9dcc24 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-10-281548684747
24fab011c0-6924-653a-832f-c5a9261790e2 (view SPL)Hydrocodone Bitartrate CII and AcetaminophenOral Solution7.5 mg/325 mg per 15 mL Rx onlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2014-09-152007130704

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