"0378-8043-21" National Drug Code (NDC)

Clobazam 1 BOTTLE, GLASS in 1 CARTON (0378-8043-21) / 120 mL in 1 BOTTLE, GLASS
(Mylan Pharmaceuticals Inc.)

NDC Code0378-8043-21
Package Description1 BOTTLE, GLASS in 1 CARTON (0378-8043-21) / 120 mL in 1 BOTTLE, GLASS
Product NDC0378-8043
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameClobazam
Non-Proprietary NameClobazam
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20181107
Marketing Category NameANDA
Application NumberANDA211259
ManufacturerMylan Pharmaceuticals 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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