NDC 63629-3141

Ambien CR

Zolpidem Tartrate

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

Product ID63629-3141_5fb4a750-ce07-07e3-f66a-46b027d5d03c
NDC63629-3141
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 NameBryant Ranch Prepack
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength13 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 63629-3141-3

90 TABLET, COATED in 1 BOTTLE (63629-3141-3)
Marketing Start Date2009-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3141-6 [63629314106]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-29

NDC 63629-3141-2 [63629314102]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-29

NDC 63629-3141-5 [63629314105]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-29

NDC 63629-3141-1 [63629314101]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-29

NDC 63629-3141-4 [63629314104]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-29

NDC 63629-3141-3 [63629314103]

Ambien CR TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

OpenFDA Data

SPL SET ID:0abb0285-f09c-2110-e570-542dae5fab1a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854882
  • 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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