NDC 21695-319

Ambien CR

Zolpidem Tartrate

Ambien CR is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Zolpidem Tartrate.

Product ID21695-319_e242ca9c-63bc-44a3-abcf-99632e7703fa
NDC21695-319
Product TypeHuman Prescription Drug
Proprietary NameAmbien CR
Generic NameZolpidem Tartrate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2009-06-30
Marketing CategoryNDA / NDA
Application NumberNDA021774
Labeler NameRebel Distributors Corp.
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength6 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 21695-319-30

30 TABLET, COATED in 1 BOTTLE (21695-319-30)
Marketing Start Date2009-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-319-30 [21695031930]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE6.25 mg/1

OpenFDA Data

SPL SET ID:968b5154-3c38-4f20-bbeb-495bcb91cc2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854894
  • 854882
  • 854896
  • 854880

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Ambien CR" or generic name "Zolpidem Tartrate"

    NDCBrand NameGeneric Name
    21695-213Ambien CRAmbien CR
    21695-319Ambien CRAmbien CR
    49999-763Ambien CRAmbien CR
    55289-205Ambien CRAmbien CR
    63629-3141Ambien CRAmbien CR
    0024-5401Ambienzolpidem tartrate
    0024-5421Ambienzolpidem tartrate
    0024-5501Ambienzolpidem tartrate
    0024-5521Ambienzolpidem tartrate
    0037-6010EdluarZolpidem Tartrate
    0037-6050EdluarZolpidem Tartrate
    0054-0086Zolpidem Tartratezolpidem tartrate
    0054-0087Zolpidem Tartratezolpidem tartrate
    0093-0073Zolpidem TartrateZolpidem Tartrate
    0093-0074Zolpidem TartrateZolpidem Tartrate

    Trademark Results [Ambien CR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMBIEN CR
    AMBIEN CR
    78360253 3265679 Live/Registered
    SANOFI
    2004-01-30
    AMBIEN CR
    AMBIEN CR
    78317645 3276106 Live/Registered
    SANOFI
    2003-10-23
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