"0713-5421-01" National Drug Code (NDC)

Ambien 100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01)
(Cosette Pharmaceuticals, Inc.)

NDC Code0713-5421-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01)
Product NDC0713-5421
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmbien
Non-Proprietary NameZolpidem Tartrate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20250207
Marketing Category NameNDA
Application NumberNDA019908
ManufacturerCosette Pharmaceuticals, Inc.
Substance NameZOLPIDEM TARTRATE
Strength10
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA ScheduleCIV

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