FDA.reportPublic FDA data

resmetirom 80 MG Oral Tablet [Rezdiffra]

RxCUI
2677913
RxNorm name
resmetirom 80 MG Oral Tablet [Rezdiffra]
Display name
resmetirom 80 MG Oral Tablet [Rezdiffra]
Full name
resmetirom 80 MG Oral Tablet [Rezdiffra]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

RxNav Current And Historical NDCs#

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No records found.

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
REZDIFFRARESMETIROMMadrigal Pharmaceuticals, Inc.e67ea09f-a840-439c-86c8-f98585f978b22026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 2677913

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
e67ea09f-a840-439c-86c8-f98585f978b2Rezdiffra 80 MG Oral Tablet [PSN] · resmetirom 80 MG Oral Tablet [Rezdiffra] [SBD] · Rezdiffra 80 MG Oral Tablet [SY]33These highlights do not include all the information needed to use REZDIFFRA safely and effectively. See full prescribing information for REZDIFFRA. REZDIFFRA (resmetirom) tablets, for oral use Initial U.S. Approval: 202420251222