FDA.reportPublic FDA data

repotrectinib 160 MG Oral Capsule

RxCUI
2696876
RxNorm name
repotrectinib 160 MG Oral Capsule
Display name
repotrectinib 160 MG Oral Capsule
Full name
repotrectinib 160 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

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
AugtyroREPOTRECTINIBE.R. Squibb & Sons, L.L.C.fb526827-40ba-4462-94cf-179ae3b0cb8a2024-06-13Warnings, Adverse reactionsExact identifier
rxcui: 2696876

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
fb526827-40ba-4462-94cf-179ae3b0cb8arepotrectinib 160 MG Oral Capsule [PSN] · repotrectinib 160 MG Oral Capsule [SCD]25These highlights do not include all the information needed to use AUGTYRO safely and effectively. See full prescribing information for AUGTYRO. AUGTYRO TM (repotrectinib) capsules, for oral use Initial U.S. Approval: 202320240613