NDC 51991-982

Zolpidem Tartrate

Zolpidem Tartrate

Zolpidem Tartrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Zolpidem Tartrate.

Product ID51991-982_488991bc-4b3d-4998-a29e-d68065c8797e
NDC51991-982
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate
Generic NameZolpidem Tartrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA213592
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength13 mg/1
Pharm Classesgamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 51991-982-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-982-01)
Marketing Start Date2020-12-17
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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