FDA.reportPublic FDA data

elacestrant 345 MG Oral Tablet [Orserdu]

RxCUI
2628489
RxNorm name
elacestrant 345 MG Oral Tablet [Orserdu]
Display name
elacestrant 345 MG Oral Tablet [Orserdu]
Full name
elacestrant 345 MG Oral Tablet [Orserdu]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORSERDUELACESTRANTStemline Therapeutics, Inc.aa66ae5c-2bd2-4444-8178-b55651e054ef2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2628489

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
aa66ae5c-2bd2-4444-8178-b55651e054efOrserdu 345 MG Oral Tablet [PSN] · elacestrant 345 MG Oral Tablet [Orserdu] [SBD] · Orserdu 345 MG Oral Tablet [SY]35These highlights do not include all the information needed to use ORSERDU safely and effectively. See full prescribing information for ORSERDU. ORSERDU™ (elacestrant) tablets, for oral use Initial U.S. Approval: 202320240802