"0378-6805-01" National Drug Code (NDC)

Zaleplon 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6805-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6805-01
Package Description100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6805-01)
Product NDC0378-6805
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZaleplon
Non-Proprietary NameZaleplon
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20080606
Marketing Category NameANDA
Application NumberANDA077238
ManufacturerMylan Pharmaceuticals Inc.
Substance NameZALEPLON
Strength5
Strength Unitmg/1
Pharmacy Classesgamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
DEA ScheduleCIV

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