"0591-2282-10" National Drug Code (NDC)

Zolpidem Tartrate 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2282-10)
(Actavis Pharma, Inc.)

NDC Code0591-2282-10
Package Description1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2282-10)
Product NDC0591-2282
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZolpidem Tartrate
Non-Proprietary NameZolpidem Tartrate
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20130325
Marketing Category NameANDA
Application NumberANDA090153
ManufacturerActavis Pharma, Inc.
Substance NameZOLPIDEM TARTRATE
Strength12.5
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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