"51167-809-01" National Drug Code (NDC)

NDC Code	51167-809-01
Package Description	4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC	51167-809
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Orkambi
Non-Proprietary Name	Lumacaftor And Ivacaftor
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20150702
Marketing Category Name	NDA
Application Number	NDA206038
Manufacturer	Vertex Pharmaceuticals Incorporated
Substance Name	IVACAFTOR; LUMACAFTOR
Strength	125; 200
Strength Unit	mg/1; mg/1
Pharmacy Classes	Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]