NDC 63629-3548

Zolpidem Tartrate

Zolpidem Tartrate

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

Product ID63629-3548_7773ba02-33ee-496c-a3a1-3299a5769ad0
NDC63629-3548
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate
Generic NameZolpidem Tartrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA078616
Labeler NameBryant Ranch Prepack
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength10 mg/1
Pharm Classesgamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-3548-1

30 TABLET, FILM COATED in 1 BOTTLE (63629-3548-1)
Marketing Start Date2008-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3548-1 [63629354801]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-6 [63629354806]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-5 [63629354805]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-4 [63629354804]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-0 [63629354800]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-16
Inactivation Date2019-11-27

NDC 63629-3548-3 [63629354803]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-2 [63629354802]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-9 [63629354809]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-16
Inactivation Date2019-11-27

NDC 63629-3548-8 [63629354808]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

NDC 63629-3548-7 [63629354807]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-21
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

OpenFDA Data

SPL SET ID:f5b905ec-5b95-bf90-60ba-3355df50acf0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854873

    • 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
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