NDC 60760-116

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 St Marys Medical Park Pharmacy. The primary component is Zolpidem Tartrate.

Product ID60760-116_77e68d0b-c9f6-b796-e053-2991aa0a3918
NDC60760-116
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate Extended Release
Generic NameZolpidem Tartrate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-01-10
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA078148
Labeler NameSt Marys Medical Park Pharmacy
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

Packaging

NDC 60760-116-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-116-30)
Marketing Start Date2013-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60760-116-30 [60760011630]

Zolpidem Tartrate Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078148
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-10
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

OpenFDA Data

SPL SET ID:de7a700d-2757-40c2-8e50-9a6b106ab011
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
    60760-116Zolpidem 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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