FDA.reportPublic FDA data

Kalydeco

Product NDC
51167-785
11-digit product format
511670785
Labeler code
51167
Product ID
51167-785_13eb3fc2-0dac-4ada-96a8-a2e0cea711b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivacaftor
Dosage form
GRANULE
Route
ORAL
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA207925
Marketing category
NDA
Marketing start
2023-05-03
Substance
IVACAFTOR
Active strength
5.8 mg/1
Pharmacologic classes
Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kalydeco
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVACAFTOR5.8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y740ILL1Z
Rxcui1243046, 1243052, 1606862, 1606866, 1606868, 1606870, 2166399, 2166401, 2636787, 2636789, 2636791, 2636793

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3345c65e-7c51-4ee3-a410-af7ec8592f92Product name220231010
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
31b21435-431d-4752-a7c5-89c6a41c6338Product name420230626
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
eaf14f5a-a483-45c2-b6bb-bda37f923e37Product name120180508
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
1c108d2a-865b-9f48-5b3a-b52233297e1dProduct name220150417
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-785-01Kalydeco56 in 1 CARTONGRANULE5636

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51167-785-01EA - Each51167-785cc28e22b-b160-4775-ad40-979a1edf904312023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ivacaftorACTIVE INGREDIENT1Y740ILL1ZKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
ivacaftorACTIVE MOIETY1Y740ILL1ZKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
AMMONIAINACTIVE INGREDIENT5138Q19F1XKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
MANNITOLINACTIVE INGREDIENT3OWL53L36AKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SHELLACINACTIVE INGREDIENT46N107B71OKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
TALCINACTIVE INGREDIENT7SEV7J4R1UKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-785KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]32Current NDC, 1 package rows20240628_0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2636787ivacaftor 13.4 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243046ivacaftor 150 MG Oral TabletPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166399ivacaftor 25 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636791ivacaftor 5.8 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606862ivacaftor 50 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606868ivacaftor 75 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636789kalydeco 13.4 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243052kalydeco 150 MG Oral TabletPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166401kalydeco 25 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636793kalydeco 5.8 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606866kalydeco 50 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606870kalydeco 75 MG Oral GranulesPSN0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636789ivacaftor 13.4 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243052ivacaftor 150 MG Oral Tablet [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166401ivacaftor 25 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636793ivacaftor 5.8 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606866ivacaftor 50 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606870ivacaftor 75 MG Oral Granules [Kalydeco]SBD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636787ivacaftor 13.4 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243046ivacaftor 150 MG Oral TabletSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166399ivacaftor 25 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636791ivacaftor 5.8 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606862ivacaftor 50 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606868ivacaftor 75 MG Oral GranulesSCD0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636789Kalydeco 13.4 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1243052Kalydeco 150 MG Oral TabletSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2166401Kalydeco 25 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
2636793Kalydeco 5.8 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606866Kalydeco 50 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536
1606870Kalydeco 75 MG Oral GranulesSY0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe2536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51167-785-015116707850156 GRANULE in 1 CARTON (51167-785-01) 56 granule2023-05-03NoNoHistorical