"68382-624-31" National Drug Code (NDC)

Roflumilast 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-624-31
Package Description1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK
Product NDC68382-624
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoflumilast
Non-Proprietary NameRoflumilast
Dosage FormTABLET
UsageORAL
Start Marketing Date20230518
Marketing Category NameANDA
Application NumberANDA208303
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameROFLUMILAST
Strength250
Strength Unitug/1
Pharmacy ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]

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