NDC 61919-803

AMBIEN

Zolpidem Tartrate

AMBIEN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Zolpidem Tartrate.

Product ID61919-803_33d47ab6-9b85-58b0-e054-00144ff8d46c
NDC61919-803
Product TypeHuman Prescription Drug
Proprietary NameAMBIEN
Generic NameZolpidem Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-01-28
Marketing CategoryANDA / ANDA
Application NumberANDA076410
Labeler NameDIRECT RX
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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-803-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-803-30)
Marketing Start Date2016-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-803-30 [61919080330]

AMBIEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-28

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

OpenFDA Data

SPL SET ID:33d47ab6-9b84-58b0-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854873
  • 854875

    • 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" or generic name "Zolpidem Tartrate"

    NDCBrand NameGeneric Name
    0024-5401Ambienzolpidem tartrate
    0024-5421Ambienzolpidem tartrate
    0024-5501Ambienzolpidem tartrate
    0024-5521Ambienzolpidem tartrate
    21695-212AmbienAmbien
    21695-211AmbienAmbien
    61919-948AMBIENAMBIEN
    61919-803AMBIENAMBIEN
    80425-0087AmbienAmbien
    80425-0060AmbienAmbien
    80425-0061AmbienAmbien
    80425-0059AmbienAmbien
    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]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMBIEN
    AMBIEN
    74345754 1808770 Live/Registered
    SANOFI
    1993-01-05
    AMBIEN
    AMBIEN
    74149493 not registered Dead/Abandoned
    G. D. Searle & Co.
    1991-03-20
    AMBIEN
    AMBIEN
    74128184 not registered Dead/Abandoned
    G. D. Searle & Co.
    1991-01-07
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