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"0054-0086-25" National Drug Code (NDC)

Zolpidem Tartrate 100 TABLET, FILM COATED in 1 BOTTLE (0054-0086-25)
(Roxane Laboratories, Inc)

NDC Code0054-0086-25
Package Description100 TABLET, FILM COATED in 1 BOTTLE (0054-0086-25)
Product NDC0054-0086
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZolpidem Tartrate
Non-Proprietary NameZolpidem Tartrate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20070427
Marketing Category NameANDA
Application NumberANDA077214
ManufacturerRoxane Laboratories, Inc
Substance NameZOLPIDEM TARTRATE
Strength5
Strength Unitmg/1
Pharmacy Classesgamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]
DEA ScheduleCIV

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