"42571-369-05" National Drug Code (NDC)

Roflumilast 500 TABLET in 1 BOTTLE (42571-369-05)
(Micro Labs Limited)

NDC Code42571-369-05
Package Description500 TABLET in 1 BOTTLE (42571-369-05)
Product NDC42571-369
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoflumilast
Non-Proprietary NameRoflumilast
Dosage FormTABLET
UsageORAL
Start Marketing Date20230501
Marketing Category NameANDA
Application NumberANDA208180
ManufacturerMicro Labs Limited
Substance NameROFLUMILAST
Strength250
Strength Unitug/1
Pharmacy ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]

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