FDA.reportPublic FDA data

elagolix 300 MG Oral Capsule

RxCUI
2371766
RxNorm name
elagolix 300 MG Oral Capsule
Display name
elagolix 300 MG Oral Capsule
Full name
elagolix 300 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

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
OriahnnELAGOLIX AND ESTRADIOL AND NORETHISTERONEAbbVie Inc.99f6eee7-7e52-6999-7eb8-488d06dd17102025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2371766

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
99f6eee7-7e52-6999-7eb8-488d06dd1710elagolix 300 MG Oral Capsule [PSN] · elagolix 300 MG Oral Capsule [SCD]241These highlights do not include all the information needed to use ORIAHNN safely and effectively. See full prescribing information for ORIAHNN. ORIAHNN ® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use Initial U.S. Approval: 202020251219