FDA.reportPublic FDA data

erdafitinib 3 MG Oral Tablet [Balversa]

RxCUI
2123137
RxNorm name
erdafitinib 3 MG Oral Tablet [Balversa]
Display name
erdafitinib 3 MG Oral Tablet [Balversa]
Full name
erdafitinib 3 MG Oral Tablet [Balversa]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

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
BALVERSAERDAFITINIBJanssen Products LP2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee2025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 2123137

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
2a8aa5c0-6c92-4566-8c45-e8f4d1fc20eeBalversa 3 MG Oral Tablet [PSN] · erdafitinib 3 MG Oral Tablet [Balversa] [SBD] · Balversa 3 MG Oral Tablet [SY]314These highlights do not include all the information needed to use BALVERSA safely and effectively. See full prescribing information for BALVERSA. BALVERSA ® (erdafitinib) tablets, for oral use Initial U.S. Approval: 201920251024