FDA.reportPublic FDA data

ospemifene 60 MG Oral Tablet

RxCUI
1370976
RxNorm name
ospemifene 60 MG Oral Tablet
Display name
ospemifene 60 MG Oral Tablet
Full name
ospemifene 60 MG Oral Tablet
Term type
SCD
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#

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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
OsphenaOSPEMIFENEDuchesnay USA, Inc.9accbcc9-78ee-4f84-9b7e-704f2ab1c4132025-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1370976

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
9accbcc9-78ee-4f84-9b7e-704f2ab1c413ospemifene 60 MG Oral Tablet [PSN] · ospemifene 60 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use OSPHENA safely and effectively. See full prescribing information for OSPHENA. OSPHENA ® (ospemifene) tablets, for oral use Initial U.S. Approval: 201320250214