NDC 61919-812

ZOLPIDEM TARTRATE ER

Zolpidem Tartrate

ZOLPIDEM TARTRATE ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Zolpidem Tartrate.

Product ID61919-812_87d89d5e-19af-1a66-e053-2995a90a2f29
NDC61919-812
Product TypeHuman Prescription Drug
Proprietary NameZOLPIDEM TARTRATE ER
Generic NameZolpidem Tartrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA090107
Labeler NameDIRECT RX
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 Through2020-12-31

Packaging

NDC 61919-812-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-812-30)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-812-30 [61919081230]

ZOLPIDEM TARTRATE ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Pharmacological Class

  • gamma-Aminobutyric Acid-ergic Agonist [EPC]
  • GABA A Agonists [MoA]
  • Pyridines [CS]
  • Central Nervous System Depression [PE]
  • gamma-Aminobutyric Acid-ergic Agonist [EPC]
  • GABA A Agonists [MoA]
  • Pyridines [CS]
  • Central Nervous System Depression [PE]

NDC Crossover Matching brand name "ZOLPIDEM TARTRATE ER" or generic name "Zolpidem Tartrate"

NDCBrand NameGeneric Name
61919-812ZOLPIDEM TARTRATE ERZOLPIDEM TARTRATE ER
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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