Kalydeco
These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO (ivacaftor) tablets, for oral useKALYDECO (ivacaftor) oral granulesInitial U.S. Approval: 2012
Approved
Approval ID
0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Vertex Pharmaceuticals Incorporated
DUNS: 602478257
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-300
Application NumberNDA207925
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivacaftor
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (9)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ivacaftorActive
Quantity: 50 mg in 1 1
Code: 1Y740ILL1Z
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-400
Application NumberNDA207925
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivacaftor
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ivacaftorActive
Quantity: 75 mg in 1 1
Code: 1Y740ILL1Z
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-600
Application NumberNDA207925
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivacaftor
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (9)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ivacaftorActive
Quantity: 25 mg in 1 1
Code: 1Y740ILL1Z
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-770
Application NumberNDA207925
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivacaftor
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ivacaftorActive
Quantity: 13.4 mg in 1 1
Code: 1Y740ILL1Z
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-785
Application NumberNDA207925
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivacaftor
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ivacaftorActive
Quantity: 5.8 mg in 1 1
Code: 1Y740ILL1Z
Classification: ACTIB
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-200
Application NumberNDA203188
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivacaftor
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2023
FDA Product Classification
INGREDIENTS (18)
ivacaftorActive
Quantity: 150 mg in 1 1
Code: 1Y740ILL1Z
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT