FDA.reportPublic FDA data

elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet

RxCUI
2557214
RxNorm name
elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet
Display name
elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet
Full name
elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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: 2557214

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-0f3aee135d8delexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet [PSN] · elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet [SCD]222These 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