FDA.reportPublic FDA data

vimseltinib 20 MG Oral Capsule [Romvimza]

RxCUI
2705416
RxNorm name
vimseltinib 20 MG Oral Capsule [Romvimza]
Display name
vimseltinib 20 MG Oral Capsule [Romvimza]
Full name
vimseltinib 20 MG Oral Capsule [Romvimza]
Term type
SBD
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
ROMVIMZAVIMSELTINIBDeciphera Pharmaceuticals, LLCf73c7a62-9601-4df0-810f-100f515d79ea2026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 2705416

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
f73c7a62-9601-4df0-810f-100f515d79eaRomvimza 20 MG Oral Capsule [PSN] · vimseltinib 20 MG Oral Capsule [Romvimza] [SBD] · Romvimza 20 MG Oral Capsule [SY]32These highlights do not include all the information needed to use ROMVIMZA TM safely and effectively. See full prescribing information for ROMVIMZA TM . ROMVIMZA TM (vimseltinib) capsules, for oral use Initial U.S. Approval: 202520251222