"0054-0561-50" National Drug Code (NDC)

Clobazam 1 BOTTLE in 1 CARTON (0054-0561-50) > 120 mL in 1 BOTTLE
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0561-50
Package Description1 BOTTLE in 1 CARTON (0054-0561-50) > 120 mL in 1 BOTTLE
Product NDC0054-0561
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameClobazam
Non-Proprietary NameClobazam
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20181022
Marketing Category NameANDA
Application NumberANDA209715
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameCLOBAZAM
Strength2.5
Strength Unitmg/mL
Pharmacy ClassesBenzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
DEA ScheduleCIV

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