FDA.reportPublic FDA data

darolutamide 300 MG Oral Tablet

RxCUI
2180330
RxNorm name
darolutamide 300 MG Oral Tablet
Display name
darolutamide 300 MG Oral Tablet
Full name
darolutamide 300 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

RxNav Current And Historical NDCs#

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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
NUBEQADAROLUTAMIDEBayer HealthCare Pharmaceuticals Inc.1a7cb212-56e4-4b9d-a73d-bfee7fe4735e2025-06-03Warnings, Adverse reactionsExact identifier
rxcui: 2180330

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
1a7cb212-56e4-4b9d-a73d-bfee7fe4735edarolutamide 300 MG Oral Tablet [PSN] · darolutamide 300 MG Oral Tablet [SCD]223These highlights do not include all the information needed to use NUBEQA safely and effectively. See full prescribing information for NUBEQA. NUBEQA ® (darolutamide) tablets, for oral use Initial U.S. Approval: 201920250603