zolpidem Oral Tablet

Brand(s)
Ambien
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-10-16)
Oldest Current Product
1993-04-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ZOLPIDEM
FDAOB
ORAL\TABLET\ZOLPIDEM TARTRATE
SPL Active
ORAL\TABLET, COATED\ZOLPIDEM TARTRATE
ORAL\TABLET, FILM COATED\ZOLPIDEM TARTRATE
ORAL\TABLET\ZOLPIDEM TARTRATE
SPL Moiety
ORAL\TABLET, COATED\ZOLPIDEM
ORAL\TABLET, FILM COATED\ZOLPIDEM
ORAL\TABLET\ZOLPIDEM

product(s) by strength(s)

zolpidem tartrate 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245421AmbienNDASanofi-Aventis U.S. Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATEDNDA019908c36cadf4-65a4-4466-b409-c82020b42452

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540087ANDARoxane Laboratories, Inc2007-04-27ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA077214db274f7c-c2f1-48ac-8edb-295c6af3121b
2000930074ANDATeva Pharmaceuticals Usa Inc2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA076410c784cf9d-de8f-44b6-b52f-a0e7c0d35e48
3003785310ANDAMylan Pharmaceuticals Inc.2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA076578bf1dd603-d91e-03d1-e262-d5a5b3022e07
4006036469ANDAQualitest Pharmaceuticals2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078616bda524fd-6c95-45a4-87e4-49f3f9d18f0d
5007815318ANDASandoz Inc2007-04-23ZOLPIDEM TARTRATEORALTABLET, COATEDANDA0773220553e26c-f2aa-43aa-adf9-6eb951a501d3
6167140622ANDANorthstar Rx Llc2007-05-04ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA07841351c9a29c-a285-40d0-bf3a-7e8c944ee39c
7605052605ANDAApotex Corp2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA0778842a9f6195-0f8a-4ca8-c0d9-880a290cf28f
8614420232ANDACarlsbad Technology, Inc.2007-04-23ZOLPIDEM TARTRATEORALTABLETANDA077990c8060b86-9c24-4347-8da3-5b7b3d62aa43
9633040160ANDARnabaxy Pharmaceuticals Inc.2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078055f5962f3a-a693-4f5f-b2ec-25c298f375c0
10658620160ANDAAurobindo Pharma Limited2007-05-04ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078413ea2067bd-1622-4d98-8012-2c09405aa88d

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439963ANDAWest-Ward Pharmaceutical Corp2008-04-30ZOLPIDEM TARTRATEORALTABLETANDA078129313ccc9f-7b3e-4e42-b5d8-0e27c3c72d8e
2551110479ANDADr. Reddy'S Laboratories Ltd2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA077985d4ea84f2-a13f-4335-a184-1e87702bc396

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791981ANDAKaiser Foundations Hospitals2008-10-01ZOLPIDEM TARTRATEORALTABLET, COATED007815318ANDA077322322a25e9-d48f-4d1c-839f-ba5ed4440908
2009046083ANDAMajor2009-11-02ZOLPIDEM TARTRATEORALTABLET136680008ANDA077903d34336b1-7041-4078-beda-94bc9d9f771e
3105440539ANDABlenheim Pharmacal, Inc.2013-10-03ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA07861611a7a0c7-d5c6-0839-e054-00144ff8d46c
4105440548ANDABlenheim Pharmacal, Inc.2011-01-07ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA07861611a91b50-63b5-457b-e054-00144ff88e88
5126340944ANDAApotheca, Inc2007-09-25ZOLPIDEM TARTRATEORALTABLET006036469ANDA0778847638e2bd-04c5-4ad2-8635-fb460ab4d1c3
6165900010AmbienNDAStat Rx Usa Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245421NDA01990802b5e3bb-c976-40a3-9077-64ffe637429f
7165900527ANDAStat Rx Usa Llc2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA077903b87ea23e-2d54-4d10-8f10-72d4c62f3245
8216950212AmbienNDARebel Distributors Corp2009-06-30ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245421NDA0199089dea009e-d435-4268-ab25-cf48a6c69abb
9332610173ANDAAidarex Pharmaceuticals Llc2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA07790306a454bc-50d0-45de-87db-f3e3502e3bb0
10333580420ANDARxchange Co.2014-11-20ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903503b8e97-1fd1-4b29-a9b7-7fb87727fe4e
11353560745ANDALake Erie Medical Dba Quality Care Products Llc2007-04-27ZOLPIDEM TARTRATEORALTABLET, FILM COATED000540087ANDA077214ef8d9313-4a5b-44ff-ac1d-c914c9eb3dd9
12425490548ANDAStat Rx Usa Llc2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA0786164c149192-bfdf-4da2-abac-be4fa3e17c56
13430630068ANDAPd-Rx Pharmaceuticals, Inc.2010-12-10ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785310ANDA07657878d35821-60e9-45b1-96d8-c126cb4a5cee
14430630366ANDAPd-Rx Pharmaceuticals, Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616fbbe301c-19c4-439d-8846-8e908d3e1f13
15430630639ANDAPd-Rx Pharmaceuticals, Inc.2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA07790324722308-dbb8-3a2d-e054-00144ff8d46c
16433530617ANDAAphena Pharma Solutions - Tennessee, Llc2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616cace3d8a-cbb5-4072-9bce-28219b4909ae
17458650413ANDAMedsource Pharmaceuticals2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA0779031b66047b-4782-4808-e054-00144ff8d46c
18499990037AmbienNDALake Erie Medical Dba Quality Care Products Llc2009-06-30ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245421NDA019908636532aa-821e-4696-8888-1442953d4014
19499990931ANDALake Erie Medical Dba Quality Care Products Llc2011-04-15ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA07861680996f05-e322-40c5-b3b4-c12c747a88a6
20500900493AmbienNDAA-S Medication Solutions Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245421NDA019908d76d5540-7bae-4719-8166-f2a9106338df
21504363026ANDAUnit Dose Services2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616508fda39-e503-4ff5-876d-726cddc4dfa6
22510790725ANDAMylan Institutional Inc.2007-05-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785310ANDA07657869be3294-ba4b-4393-816b-dedfa18d9947
23521250477ANDARemedyrepack Inc.2013-05-22, 2013-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA077903393bba2e-908b-4545-a7c2-ff83cfbf0aa9, 790c7842-a569-40bb-a1eb-e00db091f96e
24521250627ANDARemedyrepack Inc.2013-06-10ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA0786166011c0d3-5265-4dc8-893c-e0815e437659
25529590880ANDAH.J. Harkins Company, Inc.2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA0779039245ff4b-a11f-4afd-8fa0-842fcfee4306
26545693828AmbienNDAA-S Medication Solutions Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245421NDA01990838512baf-6bf6-4ffa-807c-02b0140c217c
27545695907ANDAA-S Medication Solutions Llc2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616f7f7b4c6-2b84-438d-ae86-5858807d9025
28548680846ANDAPhysicians Total Care, Inc.2009-07-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED605052605ANDA077884f852e2c0-74fe-4389-ba96-d0c03f624c86
29551541399ANDACardinal Health2009-11-02ZOLPIDEM TARTRATEORALTABLET009046083ANDA07790383510333-f07d-4b81-a3ae-2801d114bd31
30551542070ANDACardinal Health2009-10-14ZOLPIDEM TARTRATEORALTABLET680840226ANDA078426ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528
31551542226ANDACardinal Health2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785310ANDA0765784bb729d6-ae1e-425e-b5e3-c798052b8788
32551543449ANDACardinal Health2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED007815318ANDA07732231d13e08-b54f-469e-88d3-c96b2c5bc05d
33551545080ANDACardinal Health2011-01-28ZOLPIDEM TARTRATEORALTABLET510790725ANDA076578937e58eb-f69f-4598-bff9-85f2ae515aa0
34551546659ANDACardinal Health2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED605052605ANDA077884f1977b44-59b9-4e5e-802f-d201ef5c8783
35552890419ANDAPd-Rx Pharmaceuticals, Inc.2010-12-10ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785310ANDA07657804fefd25-53d9-47b5-8a6b-1d9eb0bf68fb
36617860120ANDARemedyrepack Inc.2014-12-16ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616d299c028-1d9e-40b3-8297-eb0da3ad660b
37619190527ANDADirect Rx2014-01-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA0786165baa7cf2-b6a6-4611-b4ad-7fe142220e2b
38631870116ANDAProficient Rx Lp2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA07861670a89366-1131-4bf5-ab1b-432b0c235465
39631870565ANDAProficient Rx Lp2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA077903eaca34da-2b12-4dd4-91b5-a8446c7bd41e
40636291256AmbienNDABryant Ranch Prepack1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245421NDA0199086a5f43de-1e07-49e4-8f87-ffa47ae18d2e
41636293548ANDABryant Ranch Prepack2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616f5b905ec-5b95-bf90-60ba-3355df50acf0
42637390526ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-06-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED167140622ANDA0784131cfe5171-26bf-4a93-8bd8-2b252c1a16ad
43647250008ANDATya Pharmaceuticals2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA07790311934d96-36f4-4c32-b14a-a665c7400f3b
44663360718ANDADispensing Solutions, Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616e617f7f2-585c-4eb5-8d35-1fc6d02ef57d, f1ebb7d5-9c00-4650-86f3-f5b0954af2ca
45672960759ANDARedpharm Drug Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET006036469ANDA078616a4de4fbc-56d2-40ac-814e-0546bca5ca7c
46680840200ANDAAmerican Health Packaging2014-01-07ZOLPIDEM TARTRATEORALTABLET, COATED007815318ANDA077322752c0ee4-5bb8-4316-9e9d-e6e6802797ba
47687889127ANDAPreferred Pharmaceuticals, Inc.2007-09-05ZOLPIDEM TARTRATEORALTABLET136680008ANDA077903a9ac3d4e-f502-41e3-95c0-0d334584566d
48687889905ANDAPreferred Pharmaceuticals, Inc.2012-01-30ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616f0c8d2e8-216d-4605-9040-27d01bbba9ac
49759210469ANDALife Line Home Care Services, Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036469ANDA078616bc09674c-221f-40d8-9fd4-6da672496b3a
50762370258ANDAMckesson Contract Packaging2011-10-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED007815318ANDA0773225c438434-208d-4e59-a450-e0dc2bfbb16f

zolpidem tartrate 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245401AmbienNDASanofi-Aventis U.S. Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATEDNDA019908c36cadf4-65a4-4466-b409-c82020b42452

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540086ANDARoxane Laboratories, Inc2007-04-27ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA077214db274f7c-c2f1-48ac-8edb-295c6af3121b
2000930073ANDATeva Pharmaceuticals Usa Inc2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA076410c784cf9d-de8f-44b6-b52f-a0e7c0d35e48
3003785305ANDAMylan Pharmaceuticals Inc.2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA076578bf1dd603-d91e-03d1-e262-d5a5b3022e07
4006036468ANDAQualitest Pharmaceuticals2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078616bda524fd-6c95-45a4-87e4-49f3f9d18f0d
5007815317ANDASandoz Inc2007-04-23ZOLPIDEM TARTRATEORALTABLET, COATEDANDA0773220553e26c-f2aa-43aa-adf9-6eb951a501d3
6136680007ANDATorrent Pharmaceuticals Limited2007-09-05ZOLPIDEM TARTRATEORALTABLETANDA0779031584bad1-7bf4-4805-bdd9-7eb0fac92721
7167140621ANDANorthstar Rx Llc2007-05-04ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA07841351c9a29c-a285-40d0-bf3a-7e8c944ee39c
8556480714ANDAWockhardt Limited2007-05-15ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078426ab34bf06-cd41-41ae-b20b-73c5859b2fab
9605052604ANDAApotex Corp2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA0778842a9f6195-0f8a-4ca8-c0d9-880a290cf28f
10614420231ANDACarlsbad Technology, Inc.2007-04-23ZOLPIDEM TARTRATEORALTABLETANDA077990c8060b86-9c24-4347-8da3-5b7b3d62aa43
11633040159ANDARnabaxy Pharmaceuticals Inc.2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078055f5962f3a-a693-4f5f-b2ec-25c298f375c0
12646790714ANDAWockhardt Usa Llc.2007-05-15ZOLPIDEM TARTRATEORALTABLETANDA0784267b577a38-4a41-4926-9b40-2d41193130f5
13658620159ANDAAurobindo Pharma Limited2007-05-04ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA078413ea2067bd-1622-4d98-8012-2c09405aa88d
14672960537ANDARedpharm Drug Inc.2007-05-04ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA07841320dc1daf-4732-404d-9904-e046991ce59e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439962ANDAWest-Ward Pharmaceutical Corp2008-04-30ZOLPIDEM TARTRATEORALTABLETANDA078129313ccc9f-7b3e-4e42-b5d8-0e27c3c72d8e
2551110478ANDADr. Reddy'S Laboratories Ltd2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATEDANDA077985d4ea84f2-a13f-4335-a184-1e87702bc396

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790184ANDAKaiser Foundations Hospitals2015-09-15ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785305ANDA076578f7fff7f5-58bb-4b9e-99dc-8a923aa6eb30
2001791980ANDAKaiser Foundations Hospitals2008-10-01ZOLPIDEM TARTRATEORALTABLET, COATED007815317ANDA077322322a25e9-d48f-4d1c-839f-ba5ed4440908
3009046082ANDAMajor2009-11-02ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903d34336b1-7041-4078-beda-94bc9d9f771e
4105440540ANDABlenheim Pharmacal, Inc.2013-10-03ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA07861611a7a0c7-d5c6-0839-e054-00144ff8d46c
5126340943ANDAApotheca, Inc2007-07-25ZOLPIDEM TARTRATEORALTABLET006036468ANDA0778847638e2bd-04c5-4ad2-8635-fb460ab4d1c3
6165900009AmbienNDAStat Rx Usa Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245401NDA01990802b5e3bb-c976-40a3-9077-64ffe637429f
7165900528ANDAStat Rx Usa Llc2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903b87ea23e-2d54-4d10-8f10-72d4c62f3245
8216950211AmbienNDARebel Distributors Corp2009-06-30ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245401NDA0199089dea009e-d435-4268-ab25-cf48a6c69abb
9216950506ANDARebel Distributors Corp2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA0779037efb19d9-32bb-4737-ac7f-2ec21eca255c
10332610172ANDAAidarex Pharmaceuticals Llc2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA07790306a454bc-50d0-45de-87db-f3e3502e3bb0
11333580439ANDARxchange Co.2014-11-27ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903b1a74192-3f4b-4e08-b6cd-19cefa0125e6
12353560645ANDALake Erie Medical Dba Quality Care Products Llc2007-04-27ZOLPIDEM TARTRATEORALTABLET, FILM COATED000540086ANDA077214ef8d9313-4a5b-44ff-ac1d-c914c9eb3dd9
13433530620ANDAAphena Pharma Solutions - Tennessee, Llc2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA078616cace3d8a-cbb5-4072-9bce-28219b4909ae
14499990932ANDALake Erie Medical Dba Quality Care Products Llc2011-11-07ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA0786165e14c50e-27da-470b-a519-b26fd74cc501
15500900492AmbienNDAA-S Medication Solutions Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245401NDA019908d76d5540-7bae-4719-8166-f2a9106338df
16500901022ANDAA-S Medication Solutions Llc2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA07790359cc61da-838e-4add-b2d6-42b2b283a000
17504363030ANDAUnit Dose Services2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA078616e28b0df4-b052-4588-8a45-d17797116c3f
18510790724ANDAMylan Institutional Inc.2007-05-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785305ANDA07657869be3294-ba4b-4393-816b-dedfa18d9947
19545693827AmbienNDAA-S Medication Solutions Llc1993-04-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED000245401NDA01990838512baf-6bf6-4ffa-807c-02b0140c217c
20545695906ANDAA-S Medication Solutions Llc2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA078616f7f7b4c6-2b84-438d-ae86-5858807d9025
21548680845ANDAPhysicians Total Care, Inc.2007-10-09ZOLPIDEM TARTRATEORALTABLET, FILM COATED605052604ANDA077884f852e2c0-74fe-4389-ba96-d0c03f624c86
22551541398ANDACardinal Health2009-11-02ZOLPIDEM TARTRATEORALTABLET009046082ANDA07790383510333-f07d-4b81-a3ae-2801d114bd31
23551542069ANDACardinal Health2009-10-14ZOLPIDEM TARTRATEORALTABLET680840225ANDA078426ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528
24551542225ANDACardinal Health2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785305ANDA0765784bb729d6-ae1e-425e-b5e3-c798052b8788
25551543448ANDACardinal Health2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED007815317ANDA07732231d13e08-b54f-469e-88d3-c96b2c5bc05d
26551545079ANDACardinal Health2011-01-28ZOLPIDEM TARTRATEORALTABLET510790724ANDA076578937e58eb-f69f-4598-bff9-85f2ae515aa0
27551546658ANDACardinal Health2007-04-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED605052604ANDA077884f1977b44-59b9-4e5e-802f-d201ef5c8783
28552890399ANDAPd-Rx Pharmaceuticals, Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA078616c1e38416-5ece-4b88-8793-b49032c13672
29607600515ANDASt Marys Medical Park Pharmacy2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA07790389cfb1d5-437c-4c13-8f9b-b6851ffba87b
30619190528ANDADirect Rx2014-01-01ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA0786160ca400d2-4864-43de-bd2f-cda62eb0ab1e
31619190751ANDADirect Rx2015-01-01ZOLPIDEM TARTRATEORALTABLET136680007ANDA07790368062bb7-ef75-4540-b6c0-26bc57a80f67
32631870115ANDAProficient Rx Lp2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA07861670a89366-1131-4bf5-ab1b-432b0c235465
33631870558ANDAProficient Rx Lp2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903e1f43bde-efba-42be-adef-94e1ef6664fd
34636293549ANDABryant Ranch Prepack2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903413b6f65-101e-e2cf-0802-711d080b851b
35636295498ANDABryant Ranch Prepack2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA0786166297901a-6495-4a1e-80ac-84475f7dfe0c
36663360460ANDADispensing Solutions, Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA07861636202145-15cc-47b9-9706-b7102da8586f
37672960619ANDARedpharm Drug Inc.2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA0779038a0a454e-b18e-4d89-bf16-943c4c968fe2
38672960803ANDARedpharm Drug Inc.2008-11-21ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA078616ff6c0109-e6f3-4920-83f3-6e39fd28a118
39680840189ANDAAmerican Health Packaging2014-01-07ZOLPIDEM TARTRATEORALTABLET, COATED007815317ANDA077322752c0ee4-5bb8-4316-9e9d-e6e6802797ba
40687889126ANDAPreferred Pharmaceuticals, Inc.2007-09-05ZOLPIDEM TARTRATEORALTABLET136680007ANDA077903a9ac3d4e-f502-41e3-95c0-0d334584566d
41687889278ANDAPreferred Pharmaceuticals, Inc.2015-02-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED003785305ANDA076578b2d67196-f997-49de-8a89-0622c65f794e
42687889282ANDAPreferred Pharmaceuticals, Inc.2015-02-23ZOLPIDEM TARTRATEORALTABLET, FILM COATED658620159ANDA07841368ee4878-5a63-4ea8-a1b6-88fec4001d83
43687889904ANDAPreferred Pharmaceuticals, Inc.2012-01-30ZOLPIDEM TARTRATEORALTABLET, FILM COATED006036468ANDA078616f0c8d2e8-216d-4605-9040-27d01bbba9ac
44762370257ANDAMckesson Contract Packaging2011-10-20ZOLPIDEM TARTRATEORALTABLET, FILM COATED007815317ANDA0773225c438434-208d-4e59-a450-e0dc2bfbb16f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076062ZOLPIDEM TARTRATETrueVIVIMED LABS ALATHUR PRIVATE LTD2007-04-23ANDA076062_001, ANDA076062_002
2ANDA076410ZOLPIDEM TARTRATETEVA PHARMACEUTICALS USA INC2007-04-23ANDA076410_001, ANDA076410_002
3ANDA076578ZOLPIDEM TARTRATEMYLAN PHARMACEUTICALS INC2007-04-23ANDA076578_001, ANDA076578_002
4ANDA077214ZOLPIDEM TARTRATEROXANE LABORATORIES INC2007-04-23ANDA077214_001, ANDA077214_002
5ANDA077288ZOLPIDEM TARTRATETrueMUTUAL PHARMACAL CO2007-04-23ANDA077288_001, ANDA077288_002
6ANDA077322ZOLPIDEM TARTRATELEK PHARMACEUTICALS DD2007-04-23ANDA077322_001, ANDA077322_002
7ANDA077359ZOLPIDEM TARTRATESUN PHARMACEUTICAL INDUSTRIES INC2007-04-23ANDA077359_001, ANDA077359_002
8ANDA077388ZOLPIDEM TARTRATECIPLA LTD2012-07-30ANDA077388_001, ANDA077388_002
9ANDA077540ZOLPIDEM TARTRATETrueSYNTHON PHARMACEUTICALS LTD2007-04-23ANDA077540_001, ANDA077540_002
10ANDA077773ZOLPIDEM TARTRATETrueWATSON LABORATORIES INC2007-04-23ANDA077773_001, ANDA077773_002
11ANDA077884ZOLPIDEM TARTRATEAPOTEX INC2007-04-23ANDA077884_001, ANDA077884_002
12ANDA077903ZOLPIDEM TARTRATETORRENT PHARMACEUTICALS LTD2007-08-17ANDA077903_001, ANDA077903_002
13ANDA077985ZOLPIDEM TARTRATETrueDR REDDYS LABORATORIES LTD2007-04-23ANDA077985_001, ANDA077985_002
14ANDA077990ZOLPIDEM TARTRATECARLSBAD TECHNOLOGY INC2007-04-23ANDA077990_001, ANDA077990_002
15ANDA078016ZOLPIDEM TARTRATETrueMYLAN PHARMACEUTICALS INC2007-04-23ANDA078016_001, ANDA078016_002
16ANDA078055ZOLPIDEM TARTRATESUN PHARMACEUTICAL INDUSTRIES LTD2007-04-23ANDA078055_001, ANDA078055_002
17ANDA078129ZOLPIDEM TARTRATETrueHIKMA PHARMACEUTICALS2008-04-30ANDA078129_001, ANDA078129_002
18ANDA078184ZOLPIDEM TARTRATEINVAGEN PHARMACEUTICALS INC2007-09-07ANDA078184_001, ANDA078184_002
19ANDA078413ZOLPIDEM TARTRATEAUROBINDO PHARMA LTD2007-05-04ANDA078413_001, ANDA078413_002
20ANDA078426ZOLPIDEM TARTRATEWOCKHARDT LTD2007-05-15ANDA078426_001, ANDA078426_002
21ANDA078616ZOLPIDEM TARTRATEVINTAGE PHARMACEUTICALS LLC2008-11-21ANDA078616_001, ANDA078616_002
22NDA019908AMBIENSANOFI AVENTIS US LLC1992-12-16NDA019908_001, NDA019908_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076062_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
2ANDA076062_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
3ANDA076410_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
4ANDA076410_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
5ANDA076578_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
6ANDA076578_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
7ANDA077214_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
8ANDA077214_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
9ANDA077288_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
10ANDA077288_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
11ANDA077322_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
12ANDA077322_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
13ANDA077359_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
14ANDA077359_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
15ANDA077388_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2012-07-30ZOLPIDEM TARTRATE
16ANDA077388_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2012-07-30ZOLPIDEM TARTRATE
17ANDA077540_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
18ANDA077540_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
19ANDA077773_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
20ANDA077773_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
21ANDA077884_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
22ANDA077884_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
23ANDA077903_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-08-17ZOLPIDEM TARTRATE
24ANDA077903_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-08-17ZOLPIDEM TARTRATE
25ANDA077985_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
26ANDA077985_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
27ANDA077990_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
28ANDA077990_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
29ANDA078016_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
30ANDA078016_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2007-04-23ZOLPIDEM TARTRATE
31ANDA078055_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
32ANDA078055_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-04-23ZOLPIDEM TARTRATE
33ANDA078129_001discontinuedZOLPIDEM TARTRATE (5MG)ORALTABLETFalse2008-04-30ZOLPIDEM TARTRATE
34ANDA078129_002discontinuedZOLPIDEM TARTRATE (10MG)ORALTABLETFalse2008-04-30ZOLPIDEM TARTRATE
35ANDA078184_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-09-07ZOLPIDEM TARTRATE
36ANDA078184_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-09-07ZOLPIDEM TARTRATE
37ANDA078413_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-05-04ZOLPIDEM TARTRATE
38ANDA078413_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-05-04ZOLPIDEM TARTRATE
39ANDA078426_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2007-05-15ZOLPIDEM TARTRATE
40ANDA078426_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2007-05-15ZOLPIDEM TARTRATE
41ANDA078616_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB2008-11-21ZOLPIDEM TARTRATE
42ANDA078616_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETFalseAB2008-11-21ZOLPIDEM TARTRATE
43NDA019908_001RXZOLPIDEM TARTRATE (5MG)ORALTABLETFalseAB1992-12-16AMBIEN
44NDA019908_002RXZOLPIDEM TARTRATE (10MG)ORALTABLETTrueAB1992-12-16AMBIEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102b5e3bb-c976-40a3-9077-64ffe637429f (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien (zolpidem tartrate) tablets CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-09-183165900009, 165900010
204fefd25-53d9-47b5-8a6b-1d9eb0bf68fb (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate TabletsInitial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-11-183552890419
30553e26c-f2aa-43aa-adf9-6eb951a501d3 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM tartrate tablets, USP, for oral use C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionSandoz Inc2014-10-2814007815317, 007815318
406a454bc-50d0-45de-87db-f3e3502e3bb0 (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-10-031332610172, 332610173
50ca400d2-4864-43de-bd2f-cda62eb0ab1e (view SPL)ZOLPIDEM TARTRATEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-094619190528
611934d96-36f4-4c32-b14a-a665c7400f3b (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets, USP C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2014-01-302647250008
711a7a0c7-d5c6-0839-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM Tartrate Tablets, USP, for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-191105440539, 105440540
811a91b50-63b5-457b-e054-00144ff88e88 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM Tartrate Tablets, USP, for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-191105440548
91584bad1-7bf4-4805-bdd9-7eb0fac92721 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP, for oral use, C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionTorrent Pharmaceuticals LimitedManufacture2014-11-109136680007
101b66047b-4782-4808-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets USP, for oral use, C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-07-213458650413
111cfe5171-26bf-4a93-8bd8-2b252c1a16ad (view SPL)These highlights do not include all the information needed to use zolpidem tartrate safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate TabletsInitial U.S. Approval: 1992prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-02-052637390526
1220dc1daf-4732-404d-9904-e046991ce59e (view SPL)These highlights do not include all the information needed to use zolpidem tartrate safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate Tablets CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRedpharm Drug Inc.MANUFACTURE2011-03-051672960537
1324722308-dbb8-3a2d-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets USP, for oral use, C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-1310430630639
142a9f6195-0f8a-4ca8-c0d9-880a290cf28f (view SPL)These highlights do not include all the information needed to use ZOLPIDEM tartrate tablets, USP safely and effectively. See full prescribing information for ZOLPIDEM tartrate tablets, USP. ZOLPIDEM tartrate tablets USP, for oral use, - CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-01-307605052604, 605052605
15313ccc9f-7b3e-4e42-b5d8-0e27c3c72d8e (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets Initial U.S. Approval: 1992prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-03-078001439962, 001439963
1631d13e08-b54f-469e-88d3-c96b2c5bc05d (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem tartrate tablets for oral administration Initial U.S. Approval: 1992prescriptionHuman PrescriptionCardinal HealthREPACK2011-09-221551543448, 551543449
17322a25e9-d48f-4d1c-839f-ba5ed4440908 (view SPL)Zolpidem Tartrate TabletsThese Highlights do not include all the information needed to use zolpidem tartrate tablets. See full prescribing information for zolpidem tartrate tablets.Initial U.S. Approval:1992prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2013-06-041001791980, 001791981
1836202145-15cc-47b9-9706-b7102da8586f (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-01-312663360460
1938512baf-6bf6-4ffa-807c-02b0140c217c (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien (zolpidem tartrate) tablets C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-021545693827, 545693828
20393bba2e-908b-4545-a7c2-ff83cfbf0aa9 (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRemedyrepack Inc.2013-09-051521250477
21413b6f65-101e-e2cf-0802-711d080b851b (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS Zolpidem tartrate tablets, USP -CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2009-09-053636293549
224bb729d6-ae1e-425e-b5e3-c798052b8788 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate Tablets, USP for oral use C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionCardinal HealthREPACK2014-06-262551542225, 551542226
234c149192-bfdf-4da2-abac-be4fa3e17c56 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionStat Rx Usa LlcRELABEL, REPACK2011-03-144425490548
24503b8e97-1fd1-4b29-a9b7-7fb87727fe4e (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets, USP C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRxchange Co.repack2014-11-201333580420
25508fda39-e503-4ff5-876d-726cddc4dfa6 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-09-012504363026
2651c9a29c-a285-40d0-bf3a-7e8c944ee39c (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. ZOLPIDEM tartrate tablets, USP for oral useCIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-07-085167140621, 167140622
2759cc61da-838e-4add-b2d6-42b2b283a000 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP, for oral use, C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500901022
285baa7cf2-b6a6-4611-b4ad-7fe142220e2b (view SPL)ZOLPIDEM TARTRATEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-094619190527
295c438434-208d-4e59-a450-e0dc2bfbb16f (view SPL)These highlights do not include all the information needed to use Zolpidem Tartrate safely and effectively. See full prescribing information for Zolpidem Tartrate. Initial U.S. Approval: 1992prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-09-142762370257, 762370258
305e14c50e-27da-470b-a519-b26fd74cc501 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-12-033182499990932
316011c0d3-5265-4dc8-893c-e0815e437659 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tabletsZolpidem tartrate tablets CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250627
326297901a-6495-4a1e-80ac-84475f7dfe0c (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM Tartrate Tablets, USP,for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-03-131000636295498
33636532aa-821e-4696-8888-1442953d4014 (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien (zolpidem tartrate) tablets CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-05-2230810499990037
3468062bb7-ef75-4540-b6c0-26bc57a80f67 (view SPL)ZOLPIDEM TARTRATEprescriptionHuman PrescriptionDirect Rxrepack2015-11-122619190751
3568ee4878-5a63-4ea8-a1b6-88fec4001d83 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. ZOLPIDEM tartrate tablets, USP for oral useCIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-231687889282
3669be3294-ba4b-4393-816b-dedfa18d9947 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.ZOLPIDEM tartrate tablets USP, for oral useInitial U.S. Approval: 1992prescriptionHuman PrescriptionMylan Institutional Inc.2015-07-033510790724, 510790725
376a5f43de-1e07-49e4-8f87-ffa47ae18d2e (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN Ambien (zolpidem tartrate) tablets CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636291256
3870a89366-1131-4bf5-ab1b-432b0c235465 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-06-063631870115, 631870116
39752c0ee4-5bb8-4316-9e9d-e6e6802797ba (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM tartrate tablets, USP, for oral use C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-073680840189, 680840200
407638e2bd-04c5-4ad2-8635-fb460ab4d1c3 (view SPL)ZOLPIDEM TARTRATE, TABLETS CIVprescriptionHuman PrescriptionApotheca, Increpack2013-08-161126340943, 126340944
4178d35821-60e9-45b1-96d8-c126cb4a5cee (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate TabletsInitial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-11-183430630068
42790c7842-a569-40bb-a1eb-e00db091f96e (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-221521250477
437b577a38-4a41-4926-9b40-2d41193130f5 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets for oral administration-CIVInitial U.S. Approval : 1992prescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-05-233646790714
447efb19d9-32bb-4737-ac7f-2ec21eca255c (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZOLPIDEM TARTRATE tablet for oral use - CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-06-011216950506
4580996f05-e322-40c5-b3b4-c12c747a88a6 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2011-12-283424499990931
4683510333-f07d-4b81-a3ae-2801d114bd31 (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP,for oral use,C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionCardinal HealthREPACK2015-10-013551541398, 551541399
4789cfb1d5-437c-4c13-8f9b-b6851ffba87b (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2011-09-084607600515
488a0a454e-b18e-4d89-bf16-943c4c968fe2 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS Zolpidem tartrate tablets, USP -CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-06-035672960619
499245ff4b-a11f-4afd-8fa0-842fcfee4306 (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-08-181529590880
50937e58eb-f69f-4598-bff9-85f2ae515aa0 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate TabletsInitial U.S. Approval: 1992prescriptionHuman PrescriptionCardinal HealthREPACK2014-05-125551545079, 551545080
519dea009e-d435-4268-ab25-cf48a6c69abb (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-07-011216950211, 216950212
52a4de4fbc-56d2-40ac-814e-0546bca5ca7c (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionRedpharm Drug Inc.MANUFACTURE2011-08-051672960759
53a9ac3d4e-f502-41e3-95c0-0d334584566d (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP, for oral use, C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-233687889126, 687889127
54ab34bf06-cd41-41ae-b20b-73c5859b2fab (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets for oral administration - CIVInitial U.S. Approval : 1992prescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-05-232556480714
55b1a74192-3f4b-4e08-b6cd-19cefa0125e6 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets, USP C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRxchange Co.repack2014-11-271333580439
56b2d67196-f997-49de-8a89-0622c65f794e (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.ZOLPIDEM tartrate tablets USP, for oral useInitial U.S. Approval: 1992prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-231687889278
57b87ea23e-2d54-4d10-8f10-72d4c62f3245 (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETSZolpidem tartrate tablets, USP -CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-09-132165900527, 165900528
58bc09674c-221f-40d8-9fd4-6da672496b3a (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionLife Line Home Care Services, Inc.relabel, repack2012-03-271759210469
59bda524fd-6c95-45a4-87e4-49f3f9d18f0d (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM Tartrate Tablets, USP,for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2014-10-1511006036468, 006036469
60bf1dd603-d91e-03d1-e262-d5a5b3022e07 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.ZOLPIDEM tartrate tablets USP, for oral useInitial U.S. Approval: 1992prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-187003785305, 003785310
61c1e38416-5ece-4b88-8793-b49032c13672 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-09-0110552890399
62c36cadf4-65a4-4466-b409-c82020b42452 (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN AMBIEN (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-10-1610000245401, 000245421
63c784cf9d-de8f-44b6-b52f-a0e7c0d35e48 (view SPL)These highlights do not include all the information needed to use Zolpidem Tartrate Tablets USP safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets USP.ZOLPIDEM tartrate tablets, for oral use CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-2210000930073, 000930074
64c8060b86-9c24-4347-8da3-5b7b3d62aa43 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets ZOLPIDEM Tartrate Tablets USP, for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionCarlsbad Technology, Inc.analysis, manufacture, pack2015-04-298614420231, 614420232
65cace3d8a-cbb5-4072-9bce-28219b4909ae (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-04-102433530617, 433530620
66d299c028-1d9e-40b3-8297-eb0da3ad660b (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USPZolpidem Tartrate Tablets, USPfor oral use CIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRemedyrepack Inc.2014-12-161617860120
67d34336b1-7041-4078-beda-94bc9d9f771e (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP,for oral use,C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionMajor2015-06-119009046082, 009046083
68d4ea84f2-a13f-4335-a184-1e87702bc396 (view SPL)These highlights do not include all the information needed to use Zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. Zolpidem Tartrate Tablets C IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2011-09-093551110478, 551110479
69d76d5540-7bae-4719-8166-f2a9106338df (view SPL)These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN AMBIEN (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-01-261500900492, 500900493
70db274f7c-c2f1-48ac-8edb-295c6af3121b (view SPL)These highlights do not include all the information needed to use Zolpidem Tartrate Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets. Zolpidem Tartrate Tablets for oral administration C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-05-019000540086, 000540087
71e1f43bde-efba-42be-adef-94e1ef6664fd (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP, for oral use, C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870558
72e28b0df4-b052-4588-8a45-d17797116c3f (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-09-014504363030
73e617f7f2-585c-4eb5-8d35-1fc6d02ef57d (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-091663360718
74ea2067bd-1622-4d98-8012-2c09405aa88d (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. ZOLPIDEM tartrate tablets, USP for oral useCIVInitial U.S. Approval: 1992prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-0112658620159, 658620160
75eaca34da-2b12-4dd4-91b5-a8446c7bd41e (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem tartrate tablets USP, for oral use, C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870565
76ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets. ZOLPIDEM tartrate tablets for oral administration CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionCardinal HealthREPACK2012-03-291551542069, 551542070
77ef8d9313-4a5b-44ff-ac1d-c914c9eb3dd9 (view SPL)These highlights do not include all the information needed to use ZOLPIDEM TARTRATE safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE.Initial U.S. Approval: 1992prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-07-233937353560645, 353560745
78f0c8d2e8-216d-4605-9040-27d01bbba9ac (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets, USP safely and effectively. See full prescribing information for zolpidem tartrate tablets, USP ZOLPIDEM Tartrate Tablets, USP,for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-233687889904, 687889905
79f1977b44-59b9-4e5e-802f-d201ef5c8783 (view SPL)These highlights do not include all the information needed to use Zolpidem Tartrate Tablets, USP safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets, USP. Zolpidem Tartrate Tablets, USP - CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionCardinal HealthREPACK2012-07-031551546658, 551546659
80f1ebb7d5-9c00-4650-86f3-f5b0954af2ca (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem Tartrate Tablets, for oral use CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-06-201663360718
81f5962f3a-a693-4f5f-b2ec-25c298f375c0 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tabletsZolpidem tartrate tablets, for oral use, C-IVInitial U.S. Approval: 1992prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.API MANUFACTURE, MANUFACTURE2015-05-273633040159, 633040160
82f5b905ec-5b95-bf90-60ba-3355df50acf0 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2012-10-122636293548
83f7f7b4c6-2b84-438d-ae86-5858807d9025 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-122545695906, 545695907
84f7fff7f5-58bb-4b9e-99dc-8a923aa6eb30 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets.ZOLPIDEM tartrate tablets USP, for oral useInitial U.S. Approval: 1992prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-10-021001790184
85f852e2c0-74fe-4389-ba96-d0c03f624c86 (view SPL)These highlights do not include all the information needed to use Zolpidem Tartrate Tablets, USP safely and effectively. See full prescribing information for Zolpidem Tartrate Tablets, USP. Zolpidem Tartrate Tablets, USP - CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-027548680845, 548680846
86fbbe301c-19c4-439d-8846-8e908d3e1f13 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-08-0111430630366
87ff6c0109-e6f3-4920-83f3-6e39fd28a118 (view SPL)These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992prescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-05-207672960803

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