List of Excipients in API lumacaftor and ivacaftor

Excipients in NDA-approved (novel) drugs containing lumacaftor and ivacaftor

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Vertex Pharmaceuticals Incorporated	ORKAMBI	lumacaftor and ivacaftor	51167-809	AMMONIA	2031-06-11
Vertex Pharmaceuticals Incorporated	ORKAMBI	lumacaftor and ivacaftor	51167-809	CARMINIC ACID	2031-06-11
Vertex Pharmaceuticals Incorporated	ORKAMBI	lumacaftor and ivacaftor	51167-809	CELLULOSE, MICROCRYSTALLINE	2031-06-11
Vertex Pharmaceuticals Incorporated	ORKAMBI	lumacaftor and ivacaftor	51167-809	CROSCARMELLOSE SODIUM	2031-06-11
Vertex Pharmaceuticals Incorporated	ORKAMBI	lumacaftor and ivacaftor	51167-809	FD&C BLUE NO. 1	2031-06-11
Vertex Pharmaceuticals Incorporated	ORKAMBI	lumacaftor and ivacaftor	51167-809	FD&C BLUE NO. 2	2031-06-11

Detailed excipient profiles for lumacaftor and ivacaftor

Excipient focus: AMMONIA

lumacaftor and ivacaftor drug variants containing AMMONIA

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing AMMONIA

Company	Ingredient	NDC

Excipient focus: CARMINIC ACID

lumacaftor and ivacaftor drug variants containing CARMINIC ACID

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing CARMINIC ACID

Company	Ingredient	NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

lumacaftor and ivacaftor drug variants containing CELLULOSE, MICROCRYSTALLINE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing CELLULOSE, MICROCRYSTALLINE

Company	Ingredient	NDC

Excipient focus: CROSCARMELLOSE SODIUM

lumacaftor and ivacaftor drug variants containing CROSCARMELLOSE SODIUM

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing CROSCARMELLOSE SODIUM

Company	Ingredient	NDC

Excipient focus: FD&C BLUE NO. 1

lumacaftor and ivacaftor drug variants containing FD&C BLUE NO. 1

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing FD&C BLUE NO. 1

Company	Ingredient	NDC

Excipient focus: FD&C BLUE NO. 2

lumacaftor and ivacaftor drug variants containing FD&C BLUE NO. 2

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing FD&C BLUE NO. 2

Company	Ingredient	NDC

Excipient focus: FERROSOFERRIC OXIDE

lumacaftor and ivacaftor drug variants containing FERROSOFERRIC OXIDE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing FERROSOFERRIC OXIDE

Company	Ingredient	NDC

Excipient focus: HYPROMELLOSE ACETATE SUCCINATE 06081224

lumacaftor and ivacaftor drug variants containing HYPROMELLOSE ACETATE SUCCINATE 06081224

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing HYPROMELLOSE ACETATE SUCCINATE 06081224

Company	Ingredient	NDC

Excipient focus: MAGNESIUM STEARATE

lumacaftor and ivacaftor drug variants containing MAGNESIUM STEARATE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing MAGNESIUM STEARATE

Company	Ingredient	NDC

Excipient focus: POLYETHYLENE GLYCOL 3350

lumacaftor and ivacaftor drug variants containing POLYETHYLENE GLYCOL 3350

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing POLYETHYLENE GLYCOL 3350

Company	Ingredient	NDC

Excipient focus: POLYVINYL ALCOHOL

lumacaftor and ivacaftor drug variants containing POLYVINYL ALCOHOL

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing POLYVINYL ALCOHOL

Company	Ingredient	NDC

Excipient focus: POVIDONE

lumacaftor and ivacaftor drug variants containing POVIDONE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing POVIDONE

Company	Ingredient	NDC

Excipient focus: PROPYLENE GLYCOL

lumacaftor and ivacaftor drug variants containing PROPYLENE GLYCOL

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing PROPYLENE GLYCOL

Company	Ingredient	NDC

Excipient focus: SHELLAC

lumacaftor and ivacaftor drug variants containing SHELLAC

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing SHELLAC

Company	Ingredient	NDC

Excipient focus: SODIUM LAURYL SULFATE

lumacaftor and ivacaftor drug variants containing SODIUM LAURYL SULFATE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing SODIUM LAURYL SULFATE

Company	Ingredient	NDC

Excipient focus: TALC

lumacaftor and ivacaftor drug variants containing TALC

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing TALC

Company	Ingredient	NDC

Excipient focus: TITANIUM DIOXIDE

lumacaftor and ivacaftor drug variants containing TITANIUM DIOXIDE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	lumacaftor and ivacaftor	51167-809

lumacaftor and ivacaftor drug variants not containing TITANIUM DIOXIDE

Company	Ingredient	NDC