FDA.reportPublic FDA data

futibatinib 16 MG Daily Dose Pack, 4 MG (28)

RxCUI
2628205
RxNorm name
futibatinib 16 MG Daily Dose Pack, 4 MG (28)
Display name
futibatinib 16 MG Daily Dose Pack, 4 MG (28)
Full name
futibatinib 16 MG Daily Dose Pack, 4 MG (28)
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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
LYTGOBIFUTIBATINIBTAIHO PHARMACEUTICAL CO., LTD.0b1332a1-0581-4707-9bf6-1eccfa39bef42025-10-27Warnings, Adverse reactionsExact identifier
rxcui: 2628205

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
0b1332a1-0581-4707-9bf6-1eccfa39bef4{28 (futibatinib 4 MG Oral Tablet) } Pack [GPCK] · futibatinib 16 MG Daily Dose Pack, 4 MG (28) [PSN] · futibatinib 16 MG Daily Dose Pack, 4 MG (28) [SY]38These highlights do not include all the information needed to use LYTGOBI safely and effectively. See full prescribing information for LYTGOBI. LYTGOBI ® (futibatinib) tablets, for oral use Initial U.S. Approval: 202220251027