FDA.reportPublic FDA data

elafibranor 80 MG Oral Tablet

RxCUI
2684946
RxNorm name
elafibranor 80 MG Oral Tablet
Display name
elafibranor 80 MG Oral Tablet
Full name
elafibranor 80 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

RxNav Current And Historical NDCs#

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UNII Substances#

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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
IQIRVOELAFIBRANORIpsen Biopharmaceuticals, Inc.d78aa14f-6ec1-4b1d-a4ae-e48658137a252024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 2684946

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
d78aa14f-6ec1-4b1d-a4ae-e48658137a25elafibranor 80 MG Oral Tablet [PSN] · elafibranor 80 MG Oral Tablet [SCD] · elafibranor 80 MG Oral Tablet [SY]33These highlights do not include all the information needed to use IQIRVO® safely and effectively. See full prescribing information for IQIRVO. IQIRVO (elafibranor) tablets, for oral use Initial U.S. Approval: 202420240610