"0904-7399-89" National Drug Code (NDC)

Roflumilast 90 TABLET in 1 BOTTLE (0904-7399-89)
(MAJOR PHARMACEUTICALS)

NDC Code0904-7399-89
Package Description90 TABLET in 1 BOTTLE (0904-7399-89)
Product NDC0904-7399
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoflumilast
Non-Proprietary NameRoflumilast
Dosage FormTABLET
UsageORAL
Start Marketing Date20220907
Marketing Category NameANDA
Application NumberANDA208256
ManufacturerMAJOR PHARMACEUTICALS
Substance NameROFLUMILAST
Strength500
Strength Unitug/1
Pharmacy ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]

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