FDA.reportPublic FDA data

elacestrant 345 MG Oral Tablet

RxCUI
2628487
RxNorm name
elacestrant 345 MG Oral Tablet
Display name
elacestrant 345 MG Oral Tablet
Full name
elacestrant 345 MG Oral Tablet
Term type
PSN
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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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORSERDUELACESTRANTStemline Therapeutics, Inc.aa66ae5c-2bd2-4444-8178-b55651e054ef2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2628487

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-b55651e054efelacestrant 345 MG Oral Tablet [PSN] · elacestrant 345 MG Oral Tablet [SCD] · elacestrant 345 MG (equivalent to elacestrant dihydrochloride 400 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