NDC 71335-1180

ZOLPIDEM TARTRATE

Zolpidem Tartrate

ZOLPIDEM TARTRATE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Zolpidem Tartrate.

Product ID71335-1180_470877c6-4f59-41be-8b55-c2f1b05c944b
NDC71335-1180
Product TypeHuman Prescription Drug
Proprietary NameZOLPIDEM TARTRATE
Generic NameZolpidem Tartrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA078970
Labeler NameBryant Ranch Prepack
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength13 mg/1
Pharm ClassesCentral Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1180-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1180-1)
Marketing Start Date2021-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1180-1 [71335118001]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-10

NDC 71335-1180-5 [71335118005]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-10

NDC 71335-1180-2 [71335118002]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-10

NDC 71335-1180-6 [71335118006]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-10

NDC 71335-1180-3 [71335118003]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-10

NDC 71335-1180-4 [71335118004]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-10

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

OpenFDA Data

SPL SET ID:604e77ef-2cda-4efc-abfb-9af549d40fd4
Manufacturer
UNII

Pharmacological Class

  • gamma-Aminobutyric Acid-ergic Agonist [EPC]
  • GABA A Agonists [MoA]
  • Pyridines [CS]
  • Central Nervous System Depression [PE]
  • gamma-Aminobutyric Acid-ergic Agonist [EPC]
  • GABA A Agonists [MoA]
  • Pyridines [CS]
  • Central Nervous System Depression [PE]

NDC Crossover Matching brand name "ZOLPIDEM TARTRATE" or generic name "Zolpidem Tartrate"

NDCBrand NameGeneric Name
0054-0086Zolpidem Tartratezolpidem tartrate
0054-0087Zolpidem Tartratezolpidem tartrate
0093-0073Zolpidem TartrateZolpidem Tartrate
0093-0074Zolpidem TartrateZolpidem Tartrate
67544-996Zolpidem TartrateZolpidem Tartrate
68071-1895ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68071-1997Zolpidem TartrateZolpidem Tartrate
68071-1887ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68071-4089Zolpidem TartrateZolpidem Tartrate
68071-4598ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68084-523Zolpidem TartrateZolpidem Tartrate
68084-189Zolpidem TartrateZolpidem Tartrate
68180-779ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68180-780ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68788-7182Zolpidem TartrateZolpidem Tartrate
68788-7407Zolpidem TartrateZolpidem Tartrate
68788-9126ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68788-9282Zolpidem TartrateZolpidem Tartrate
68788-9278Zolpidem TartrateZolpidem Tartrate
68788-8971Zolpidem TartrateZolpidem Tartrate
68788-9127ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
68788-8970Zolpidem TartrateZolpidem Tartrate
70518-0161Zolpidem TartrateZolpidem Tartrate
70518-1663Zolpidem TartrateZolpidem Tartrate
71335-0079Zolpidem TartrateZolpidem Tartrate
71335-0154ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
71335-0283Zolpidem TartrateZolpidem Tartrate
71335-0134Zolpidem TartrateZolpidem Tartrate
71610-151Zolpidem TartrateZolpidem Tartrate
71610-192Zolpidem TartrateZolpidem Tartrate
71610-152Zolpidem TartrateZolpidem Tartrate
71610-156Zolpidem TartrateZolpidem Tartrate
75921-469Zolpidem TartrateZolpidem Tartrate
0615-8047Zolpidem TartrateZolpidem Tartrate
0615-8046Zolpidem TartrateZolpidem Tartrate
0615-8226Zolpidem TartrateZolpidem Tartrate
0615-8225Zolpidem TartrateZolpidem Tartrate
0781-5315Zolpidem tartrateZolpidem tartrate
0781-5316Zolpidem tartrateZolpidem tartrate
0781-5318Zolpidem TartrateZolpidem Tartrate
0781-5317Zolpidem TartrateZolpidem Tartrate
0904-6082ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
0904-6083ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
0955-1703Zolpidem TartrateZolpidem Tartrate
10544-539Zolpidem TartrateZolpidem Tartrate
0955-1702Zolpidem TartrateZolpidem Tartrate
10544-040ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
10544-548Zolpidem TartrateZolpidem Tartrate
10544-540Zolpidem TartrateZolpidem Tartrate
12634-944ZOLPIDEM TARTRATEZOLPIDEM TARTRATE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.