NDC 50436-0116

Zolpidem Tartrate Extended-Release

Zolpidem Tartrate

Zolpidem Tartrate Extended-Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Zolpidem Tartrate.

Product ID50436-0116_b0a2a7ca-8b8a-4a25-ac78-92f24db5091f
NDC50436-0116
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate Extended-Release
Generic NameZolpidem Tartrate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA078148
Labeler NameUnit Dose Services
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50436-0116-1

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50436-0116-1)
Marketing Start Date2017-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50436-0116-1 [50436011601]

Zolpidem Tartrate Extended-Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078148
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-01
Marketing End Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

OpenFDA Data

SPL SET ID:6691cd53-1dd5-4c5b-8395-6e8989d39a3e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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 "Zolpidem Tartrate Extended-Release" or generic name "Zolpidem Tartrate"

    NDCBrand NameGeneric Name
    10370-116Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    10370-117Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    50090-3994Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    50436-0116Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    55700-777Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    51407-555Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    51407-554Zolpidem Tartrate Extended-ReleaseZolpidem Tartrate Extended-Release
    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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