FDA.reportPublic FDA data

trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack

RxCUI
2635022
RxNorm name
trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack
Display name
trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack
Full name
trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack
Term type
PSN
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.

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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: 2635022

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{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] [BPCK] · trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack [PSN] · Trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules 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