NDC 12634-944

ZOLPIDEM TARTRATE

Zolpidem Tartrate

ZOLPIDEM TARTRATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc. The primary component is Zolpidem Tartrate.

Product ID12634-944_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4
NDC12634-944
Product TypeHuman Prescription Drug
Proprietary NameZOLPIDEM TARTRATE
Generic NameZolpidem Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA077884
Labeler NameAPOTHECA, INC
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-944-59

30 TABLET in 1 BLISTER PACK (12634-944-59)
Marketing Start Date2007-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-944-65 [12634094465]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-95 [12634094495]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-85 [12634094485]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-91 [12634094491]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-50 [12634094450]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-80 [12634094480]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-59 [12634094459]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-00 [12634094400]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-64 [12634094464]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-79 [12634094479]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-71 [12634094471]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-82 [12634094482]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

NDC 12634-944-01 [12634094401]

ZOLPIDEM TARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA077884
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

OpenFDA Data

SPL SET ID:7638e2bd-04c5-4ad2-8635-fb460ab4d1c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854873
  • 854876

    • 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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