FDA.reportPublic FDA data

duvelisib 25 MG Oral Capsule

RxCUI
2058523
RxNorm name
duvelisib 25 MG Oral Capsule
Display name
duvelisib 25 MG Oral Capsule
Full name
duvelisib 25 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

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
COPIKTRADUVELISIBSecura Bio, Ince3c5ac56-e1f6-473a-bc73-6878365347802025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2058523

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
47547f93-489c-4298-aeea-d6a37ca6cb1dduvelisib 25 MG Oral Capsule [PSN] · duvelisib 25 MG Oral Capsule [SCD]25These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 201820220211
e3c5ac56-e1f6-473a-bc73-687836534780duvelisib 25 MG Oral Capsule [PSN] · duvelisib 25 MG Oral Capsule [SCD]24These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA ® (duvelisib), capsules for oral use Initial U.S. Approval: 201820251218