"68382-969-16" National Drug Code (NDC)

Roflumilast 90 TABLET in 1 BOTTLE (68382-969-16)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-969-16
Package Description90 TABLET in 1 BOTTLE (68382-969-16)
Product NDC68382-969
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoflumilast
Non-Proprietary NameRoflumilast
Dosage FormTABLET
UsageORAL
Start Marketing Date20221003
Marketing Category NameANDA
Application NumberANDA208303
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameROFLUMILAST
Strength500
Strength Unitug/1
Pharmacy ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]

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