NDC 16714-621

Zolpidem Tartrate

Zolpidem Tartrate

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

Product ID16714-621_03a4b0da-9bc1-46d1-9aa3-56f40a7c5521
NDC16714-621
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate
Generic NameZolpidem Tartrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-05-04
Marketing CategoryANDA / ANDA
Application NumberANDA078413
Labeler NameNorthStar Rx LLC
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 Through2020-12-31

Packaging

NDC 16714-621-01

100 TABLET, FILM COATED in 1 BOTTLE (16714-621-01)
Marketing Start Date2007-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-621-11 [16714062111]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078413
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-04

NDC 16714-621-10 [16714062110]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078413
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-04

NDC 16714-621-02 [16714062102]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078413
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-05-04

NDC 16714-621-01 [16714062101]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078413
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-05-04

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

OpenFDA Data

SPL SET ID:51c9a29c-a285-40d0-bf3a-7e8c944ee39c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854873
  • 854876
  • UPC Code
  • 0316714621012
  • 0316714622019
  • Pharmacological Class

    • gamma-Aminobutyric Acid-ergic Agonist [EPC]
    • GABA A Agonists [MoA]
    • Pyridines [CS]
    • Central Nervous System Depression [PE]

    Medicade Reported Pricing

    16714062102 ZOLPIDEM TARTRATE 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714062101 ZOLPIDEM TARTRATE 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.