"69292-630-28" National Drug Code (NDC)

Roflumilast 2 BLISTER PACK in 1 CARTON (69292-630-28) / 14 TABLET in 1 BLISTER PACK
(Amici Pharma Inc.)

NDC Code69292-630-28
Package Description2 BLISTER PACK in 1 CARTON (69292-630-28) / 14 TABLET in 1 BLISTER PACK
Product NDC69292-630
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoflumilast
Non-Proprietary NameRoflumilast
Dosage FormTABLET
UsageORAL
Start Marketing Date20260205
Marketing Category NameANDA
Application NumberANDA208236
ManufacturerAmici Pharma Inc.
Substance NameROFLUMILAST
Strength250
Strength Unitug/1
Pharmacy ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]

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