FDA.reportPublic FDA data

Copiktra 25 MG Oral Capsule

RxCUI
2058525
RxNorm name
Copiktra 25 MG Oral Capsule
Display name
Copiktra 25 MG Oral Capsule
Full name
Copiktra 25 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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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: 2058525

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-d6a37ca6cb1dCopiktra 25 MG Oral Capsule [PSN] · duvelisib 25 MG Oral Capsule [Copiktra] [SBD] · Copiktra 25 MG Oral Capsule [SY]35These 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-bc73-687836534780Copiktra 25 MG Oral Capsule [PSN] · duvelisib 25 MG Oral Capsule [Copiktra] [SBD] · Copiktra 25 MG Oral Capsule [SY]34These 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