FDA.reportPublic FDA data

trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack

RxCUI
2557216
RxNorm name
trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack
Display name
trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack
Full name
trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrikaftaELEXACAFTOR, TEZACAFTOR, AND IVACAFTORVertex Pharmaceuticals Incorporatedf354423a-85c2-41c3-a9db-0f3aee135d8d2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2557216

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f354423a-85c2-41c3-a9db-0f3aee135d8d{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)] [BPCK] · trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack [PSN] · trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack [SY]322These 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: 201920260323