FDA.reportPublic FDA data

{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack

RxCUI
2371767
RxNorm name
{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack
Display name
{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack
Full name
{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack
Term type
GPCK
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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: 2371767

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
99f6eee7-7e52-6999-7eb8-488d06dd1710{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } PackGPCK41These 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
99f6eee7-7e52-6999-7eb8-488d06dd1710(elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG (28) Oral Capsule) / (elagolix 300 MG (28) Oral Capsule) PackSY41These 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