"0054-0084-25" National Drug Code (NDC)

Zaleplon 100 CAPSULE in 1 BOTTLE (0054-0084-25)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0084-25
Package Description100 CAPSULE in 1 BOTTLE (0054-0084-25)
Product NDC0054-0084
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZaleplon
Non-Proprietary NameZaleplon
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20080606
Marketing Category NameANDA
Application NumberANDA077237
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameZALEPLON
Strength5
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA ScheduleCIV

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