NDC 0143-9963

Zolpidem

Zolpidem Tartrate

Zolpidem is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceutical Corp. The primary component is Zolpidem Tartrate.

Product ID0143-9963_44d3d32b-6e68-4915-920e-ede52ed92f26
NDC0143-9963
Product TypeHuman Prescription Drug
Proprietary NameZolpidem
Generic NameZolpidem Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA078129
Labeler NameWest-ward Pharmaceutical Corp
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]
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0143-9963-01

100 TABLET in 1 BOTTLE (0143-9963-01)
Marketing Start Date2008-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9963-01 [00143996301]

Zolpidem TABLET
Marketing CategoryANDA
Application NumberANDA078129
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-04-30

NDC 0143-9963-05 [00143996305]

Zolpidem TABLET
Marketing CategoryANDA
Application NumberANDA078129
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-04-30

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

OpenFDA Data

SPL SET ID:313ccc9f-7b3e-4e42-b5d8-0e27c3c72d8e
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]

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

    NDCBrand NameGeneric Name
    0143-9962ZolpidemZolpidem
    0143-9963ZolpidemZolpidem
    71093-156ZolpidemZolpidem
    71093-155ZolpidemZolpidem
    63629-1170ZolpidemZolpidem
    63629-1171ZolpidemZolpidem
    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

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