"51167-200-01" National Drug Code (NDC)

Kalydeco 4 BLISTER PACK in 1 CARTON (51167-200-01) / 14 TABLET, FILM COATED in 1 BLISTER PACK
(Vertex Pharmaceuticals Incorporated)

NDC Code51167-200-01
Package Description4 BLISTER PACK in 1 CARTON (51167-200-01) / 14 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC51167-200
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKalydeco
Non-Proprietary NameIvacaftor
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120131
Marketing Category NameNDA
Application NumberNDA203188
ManufacturerVertex Pharmaceuticals Incorporated
Substance NameIVACAFTOR
Strength150
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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