"51167-785-01" National Drug Code (NDC)

Kalydeco 56 GRANULE in 1 CARTON (51167-785-01)
(Vertex Pharmaceuticals Incorporated)

NDC Code51167-785-01
Package Description56 GRANULE in 1 CARTON (51167-785-01)
Product NDC51167-785
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKalydeco
Non-Proprietary NameIvacaftor
Dosage FormGRANULE
UsageORAL
Start Marketing Date20230503
Marketing Category NameNDA
Application NumberNDA207925
ManufacturerVertex Pharmaceuticals Incorporated
Substance NameIVACAFTOR
Strength5.8
Strength Unitmg/1
Pharmacy ClassesChloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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