FDA.reportPublic FDA data

ivacaftor 59.5 MG Oral Granules

RxCUI
2635020
RxNorm name
ivacaftor 59.5 MG Oral Granules
Display name
ivacaftor 59.5 MG Oral Granules
Full name
ivacaftor 59.5 MG Oral Granules
Term type
SCD
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#

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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: 2635020

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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-0f3aee135d8divacaftor 59.5 MG Oral Granules [PSN] · ivacaftor 59.5 MG Oral Granules [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