FDA.reportPublic FDA data

estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet

RxCUI
2556799
RxNorm name
estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet
Display name
estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet
Full name
estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

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
MyfembreeRELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATESumitomo Pharma America, Incfc3feb73-cc84-43a8-aa32-b262460495e82025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2556799

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
fc3feb73-cc84-43a8-aa32-b262460495e8estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet [PSN] · estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet [SCD]218These highlights do not include all the information needed to use MYFEMBREE safely and effectively. See full prescribing information for MYFEMBREE. MYFEMBREE ® (relugolix, estradiol, and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 202120250904