"76420-496-01" National Drug Code (NDC)

Zolpidem Tartrate 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-01)
(Asclemed USA, Inc.)

NDC Code76420-496-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-01)
Product NDC76420-496
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZolpidem Tartrate
Non-Proprietary NameZolpidem Tartrate
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20201217
Marketing Category NameANDA
Application NumberANDA213592
ManufacturerAsclemed USA, Inc.
Substance NameZOLPIDEM TARTRATE
Strength12.5
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA ScheduleCIV

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