List of Excipients in API IVACAFTOR

Excipients in NDA-approved (novel) drugs containing IVACAFTOR

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Vertex Pharmaceuticals Incorporated	KALYDECO	ivacaftor	51167-200	AMMONIA	2030-02-13
Vertex Pharmaceuticals Incorporated	KALYDECO	ivacaftor	51167-200	CARNAUBA WAX	2030-02-13
Vertex Pharmaceuticals Incorporated	KALYDECO	ivacaftor	51167-200	CELLULOSE, MICROCRYSTALLINE	2030-02-13
Vertex Pharmaceuticals Incorporated	KALYDECO	ivacaftor	51167-200	CROSCARMELLOSE SODIUM	2030-02-13
Vertex Pharmaceuticals Incorporated	KALYDECO	ivacaftor	51167-200	FD&C BLUE NO. 2	2030-02-13
Vertex Pharmaceuticals Incorporated	KALYDECO	ivacaftor	51167-200	FERROSOFERRIC OXIDE	2030-02-13

Detailed excipient profiles for IVACAFTOR

Excipient focus: AMMONIA

IVACAFTOR drug variants containing AMMONIA

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing AMMONIA

Company	Ingredient	NDC

Excipient focus: CARNAUBA WAX

IVACAFTOR drug variants containing CARNAUBA WAX

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing CARNAUBA WAX

Company	Ingredient	NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

IVACAFTOR drug variants containing CELLULOSE, MICROCRYSTALLINE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing CELLULOSE, MICROCRYSTALLINE

Company	Ingredient	NDC

Excipient focus: CROSCARMELLOSE SODIUM

IVACAFTOR drug variants containing CROSCARMELLOSE SODIUM

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing CROSCARMELLOSE SODIUM

Company	Ingredient	NDC

Excipient focus: FD&C BLUE NO. 2

IVACAFTOR drug variants containing FD&C BLUE NO. 2

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing FD&C BLUE NO. 2

Company	Ingredient	NDC

Excipient focus: FERROSOFERRIC OXIDE

IVACAFTOR drug variants containing FERROSOFERRIC OXIDE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing FERROSOFERRIC OXIDE

Company	Ingredient	NDC

Excipient focus: HYPROMELLOSE ACETATE SUCCINATE 06081224

IVACAFTOR drug variants containing HYPROMELLOSE ACETATE SUCCINATE 06081224

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing HYPROMELLOSE ACETATE SUCCINATE 06081224

Company	Ingredient	NDC

Excipient focus: LACTOSE MONOHYDRATE

IVACAFTOR drug variants containing LACTOSE MONOHYDRATE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing LACTOSE MONOHYDRATE

Company	Ingredient	NDC

Excipient focus: MAGNESIUM STEARATE

IVACAFTOR drug variants containing MAGNESIUM STEARATE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing MAGNESIUM STEARATE

Company	Ingredient	NDC

Excipient focus: POLYETHYLENE GLYCOL 3350

IVACAFTOR drug variants containing POLYETHYLENE GLYCOL 3350

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing POLYETHYLENE GLYCOL 3350

Company	Ingredient	NDC

Excipient focus: POLYVINYL ALCOHOL

IVACAFTOR drug variants containing POLYVINYL ALCOHOL

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing POLYVINYL ALCOHOL

Company	Ingredient	NDC

Excipient focus: PROPYLENE GLYCOL

IVACAFTOR drug variants containing PROPYLENE GLYCOL

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing PROPYLENE GLYCOL

Company	Ingredient	NDC

Excipient focus: SHELLAC

IVACAFTOR drug variants containing SHELLAC

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing SHELLAC

Company	Ingredient	NDC

Excipient focus: SILICON DIOXIDE

IVACAFTOR drug variants containing SILICON DIOXIDE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing SILICON DIOXIDE

Company	Ingredient	NDC

Excipient focus: SODIUM LAURYL SULFATE

IVACAFTOR drug variants containing SODIUM LAURYL SULFATE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing SODIUM LAURYL SULFATE

Company	Ingredient	NDC

Excipient focus: TALC

IVACAFTOR drug variants containing TALC

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing TALC

Company	Ingredient	NDC

Excipient focus: TITANIUM DIOXIDE

IVACAFTOR drug variants containing TITANIUM DIOXIDE

Company	Ingredient	NDC
Vertex Pharmaceuticals Incorporated	ivacaftor	51167-200

IVACAFTOR drug variants not containing TITANIUM DIOXIDE

Company	Ingredient	NDC