FDA.reportPublic FDA data

Osphena 60 MG Oral Tablet

RxCUI
1370982
RxNorm name
Osphena 60 MG Oral Tablet
Display name
Osphena 60 MG Oral Tablet
Full name
Osphena 60 MG Oral Tablet
Term type
SY
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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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: 1370982

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-704f2ab1c413Osphena 60 MG Oral Tablet [PSN] · ospemifene 60 MG Oral Tablet [Osphena] [SBD] · Osphena 60 MG Oral Tablet [SY]34These 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