FDA.reportPublic FDA data

niraparib 100 MG / abiraterone acetate 500 MG Oral Tablet

RxCUI
2645251
RxNorm name
niraparib 100 MG / abiraterone acetate 500 MG Oral Tablet
Display name
niraparib 100 MG / abiraterone acetate 500 MG Oral Tablet
Full name
niraparib 100 MG / abiraterone acetate 500 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

RxNav Current And Historical NDCs#

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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
AKEEGANIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATEJanssen Biotech, Inc.8245a990-3268-4613-b5c5-9537858a1eb92025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 2645251

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8245a990-3268-4613-b5c5-9537858a1eb9niraparib 100 MG / abiraterone acetate 500 MG Oral TabletPSN3These highlights do not include all the information needed to use AKEEGA safely and effectively. See full prescribing information for AKEEGA. AKEEGA ® (niraparib and abiraterone acetate) tablets, for oral use Initial U.S. Approval: 202320251218
8245a990-3268-4613-b5c5-9537858a1eb9abiraterone acetate 500 MG / niraparib 100 MG (equivalent to 153.7 MG niraparib tosylate) Oral TabletSY3These highlights do not include all the information needed to use AKEEGA safely and effectively. See full prescribing information for AKEEGA. AKEEGA ® (niraparib and abiraterone acetate) tablets, for oral use Initial U.S. Approval: 202320251218
8245a990-3268-4613-b5c5-9537858a1eb9abiraterone acetate 500 MG / niraparib 100 MG Oral TabletSCD3These highlights do not include all the information needed to use AKEEGA safely and effectively. See full prescribing information for AKEEGA. AKEEGA ® (niraparib and abiraterone acetate) tablets, for oral use Initial U.S. Approval: 202320251218