FDA.reportPublic FDA data

Trikafta

Product NDC
51167-331
11-digit product format
511670331
Labeler code
51167
Product ID
51167-331_d16848f4-2958-44c0-b688-8a9b25d9032f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Elexacaftor, Tezacaftor, and Ivacaftor
Dosage form
KIT
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA212273
Marketing category
NDA
Marketing start
2019-10-21
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1243046, 1606868, 2174388, 2257011, 2257012, 2257013, 2557214, 2557215, 2557216, 2635013, 2635020, 2635021, 2635022, 2635024, 2635025, 2635026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
29f82424-66ff-4356-862a-3564547225eaProduct name120250819
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3345c65e-7c51-4ee3-a410-af7ec8592f92Product name220231010
31b21435-431d-4752-a7c5-89c6a41c6338Product name420230626
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51167-331-012024-01-30C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012024-01-30C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012024-01-30C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012024-01-30C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-08-05C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-08-05C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-08-05C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-08-05C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-07-29C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-07-29C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-07-29C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
51167-331-012022-07-29C16284748780-1e4f33bdf-af96-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA ® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-331-01Trikafta1 in 1 BLISTER PACKKIT122
51167-331-01Trikafta4 in 1 CARTONKIT422
51167-431-14Trikafta14 in 1 BLISTER PACKTABLET, FILM COATED14100 mg22
51167-531-07Trikafta7 in 1 BLISTER PACKTABLET, FILM COATED7150 mg22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51167-331-01EA - Each51167-331b1113c62-bece-480c-a5e8-28819d6d259412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-331TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]20Current NDC, Legacy NDC, 4 package rows20250215_f354423a-85c2-41c3-a9db-0f3aee135d8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2635026{28 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules) / 28 (ivacaftor 75 MG Oral Granules) } Pack [Trikafta (100 MG / 50 MG / 75 MG; 75 MG) Granules]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635022{28 (elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules) / 28 (ivacaftor 59.5 MG Oral Granules) } Pack [Trikafta (80 MG / 40 MG / 60 MG; 59.5 MG) Granules]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257013{56 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Trikafta (100 MG / 50 MG / 75 MG; 150 MG)]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557216{56 (elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack [Trikafta (50 MG / 37.5 MG / 25 MG; 75 MG)]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635025{28 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules) / 28 (ivacaftor 75 MG Oral Granules) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635021{28 (elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules) / 28 (ivacaftor 59.5 MG Oral Granules) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257012{56 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557215{56 (elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635024elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635025elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules (28) / ivacaftor 75 MG Oral Granules (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257011elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257012elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet (56) and ivacaftor 150 MG Oral Tablet (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557214elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557215elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet (56) and ivacaftor 75 MG Oral Tablet (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635013elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635021elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules (28) / ivacaftor 59.5 MG Oral Granules (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
1243046ivacaftor 150 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635020ivacaftor 59.5 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
1606868ivacaftor 75 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2174388ivacaftor 75 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257013trikafta 100 MG / 50 MG / 75 MG and 150 MG Tablet PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635026trikafta 100 MG / 50 MG / 75 MG and 75 MG Oral Granules PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557216trikafta 50 MG / 37.5 MG / 25 MG and 75 MG PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635022trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635024elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257011elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557214elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635013elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
1243046ivacaftor 150 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635020ivacaftor 59.5 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
1606868ivacaftor 75 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2174388ivacaftor 75 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635025elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules (28) / ivacaftor 75 MG Oral Granules (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257012elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet (56) and ivacaftor 150 MG Oral Tablet (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557215elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet (56) and ivacaftor 75 MG Oral Tablet (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635021elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules (28) / ivacaftor 59.5 MG Oral Granules (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257013trikafta 100 MG / 50 MG / 75 MG and 150 MG Tablet PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635026Trikafta 100 MG / 50 MG / 75 MG and 75 MG Oral Granules PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557216trikafta 50 MG / 37.5 MG / 25 MG and 75 MG PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635022Trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51167-331-01511670331014 BLISTER PACK in 1 CARTON (51167-331-01) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-431-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-531-07) 4 blister pack2019-10-210000-00-00NoNoCurrent
51167-431-145116704311414 in 1 BLISTER PACKHistorical
51167-531-07511670531077 in 1 BLISTER PACKHistorical