NDC 63187-691

Zolpidem Tartrate

Zolpidem Tartrate

Zolpidem Tartrate is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Zolpidem Tartrate.

Product ID63187-691_3f8065e2-9b67-478b-83a3-c4e6eed0fe32
NDC63187-691
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate
Generic NameZolpidem Tartrate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2007-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA077322
Labeler NameProficient Rx LP
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength5 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 63187-691-15

15 TABLET, COATED in 1 BOTTLE (63187-691-15)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-691-30 [63187069130]

Zolpidem Tartrate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA077322
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-01

NDC 63187-691-90 [63187069190]

Zolpidem Tartrate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA077322
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-01

NDC 63187-691-15 [63187069115]

Zolpidem Tartrate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA077322
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-01

NDC 63187-691-60 [63187069160]

Zolpidem Tartrate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA077322
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-01

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

OpenFDA Data

SPL SET ID:92c58053-7ed8-4a3d-a2f7-8e30c4e5a367
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]
    • 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.