FDA.reportPublic FDA data

relugolix 120 MG Oral Tablet

RxCUI
2472783
RxNorm name
relugolix 120 MG Oral Tablet
Display name
relugolix 120 MG Oral Tablet
Full name
relugolix 120 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

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
OrgovyxRELUGOLIXSumitomo Pharma America, Inc.077a92f6-9f1b-479a-87c7-c92b5db6aa9c2025-10-10Warnings, Adverse reactionsExact identifier
rxcui: 2472783

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
077a92f6-9f1b-479a-87c7-c92b5db6aa9crelugolix 120 MG Oral Tablet [PSN] · relugolix 120 MG Oral Tablet [SCD]212These highlights do not include all the information needed to use ORGOVYX safely and effectively. See full prescribing information for ORGOVYX. ORGOVYX (relugolix) tablets, for oral use Initial U.S. Approval: 202020251010