FDA.reportPublic FDA data

tipiracil 6.14 MG / trifluridine 15 MG Oral Tablet

RxCUI
1670311
RxNorm name
tipiracil 6.14 MG / trifluridine 15 MG Oral Tablet
Display name
tipiracil 6.14 MG / trifluridine 15 MG Oral Tablet
Full name
tipiracil 6.14 MG / trifluridine 15 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

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
LONSURFTRIFLURIDINE AND TIPIRACILTaiho Pharmaceutical Co., Ltd.f5beed22-d71d-4c0d-8dca-2c7317d65d852025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 1670311

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
f5beed22-d71d-4c0d-8dca-2c7317d65d85tipiracil 6.14 MG / trifluridine 15 MG Oral Tablet [PSN] · tipiracil 6.14 MG / trifluridine 15 MG Oral Tablet [SCD]215These highlights do not include all the information needed to use LONSURF safely and effectively. See full prescribing information for LONSURF. LONSURF (trifluridine and tipiracil) tablets, for oral use Initial U.S. Approval: 201520251105