FDA.reportPublic FDA data

opicapone 50 MG Oral Capsule [Ongentys]

RxCUI
2362182
RxNorm name
opicapone 50 MG Oral Capsule [Ongentys]
Display name
opicapone 50 MG Oral Capsule [Ongentys]
Full name
opicapone 50 MG Oral Capsule [Ongentys]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:12

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
ONGENTYSOPICAPONEAmneal Pharmaceuticals LLCa511a531-112e-43f8-a43f-5334b0efe9792025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 2362182

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
a511a531-112e-43f8-a43f-5334b0efe979Ongentys 50 MG Oral Capsule [PSN] · opicapone 50 MG Oral Capsule [Ongentys] [SBD] · Ongentys 50 MG Oral Capsule [SY]39These highlights do not include all the information needed to use ONGENTYS ® safely and effectively. See full prescribing information for ONGENTYS ® . ONGENTYS ( opicapone ) capsules, for oral use Initial U.S. Approval: 20 2020251015