NDC 71335-1468

Zolpidem Tartrate

Zolpidem Tartrate

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

Product ID71335-1468_2d682799-26e7-4b7a-a835-fbbc8d705dc4
NDC71335-1468
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate
Generic NameZolpidem Tartrate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA204170
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 71335-1468-1

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-1)
Marketing Start Date2020-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1468-1 [71335146801]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-15

NDC 71335-1468-5 [71335146805]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-15

NDC 71335-1468-3 [71335146803]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-15

NDC 71335-1468-6 [71335146806]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-15

NDC 71335-1468-2 [71335146802]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-15

NDC 71335-1468-4 [71335146804]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Pharmacological Class

  • 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.