"51167-500-02" National Drug Code (NDC)

NDC Code	51167-500-02
Package Description	56 PACKET in 1 CARTON (51167-500-02) / 1 GRANULE in 1 PACKET
Product NDC	51167-500
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Orkambi
Non-Proprietary Name	Lumacaftor And Ivacaftor
Dosage Form	GRANULE
Usage	ORAL
Start Marketing Date	20180807
Marketing Category Name	NDA
Application Number	NDA211358
Manufacturer	Vertex Pharmaceuticals Incorporated
Substance Name	IVACAFTOR; LUMACAFTOR
Strength	188; 150
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]