"0378-1905-93" National Drug Code (NDC)

Roflumilast 30 TABLET in 1 BOTTLE, PLASTIC (0378-1905-93)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1905-93
Package Description30 TABLET in 1 BOTTLE, PLASTIC (0378-1905-93)
Product NDC0378-1905
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoflumilast
Non-Proprietary NameRoflumilast
Dosage FormTABLET
UsageORAL
Start Marketing Date20221019
Marketing Category NameANDA
Application NumberANDA208257
ManufacturerMylan Pharmaceuticals Inc.
Substance NameROFLUMILAST
Strength500
Strength Unitug/1
Pharmacy ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]

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