FDA.reportPublic FDA data

ponatinib 45 MG Oral Tablet [Iclusig]

RxCUI
1364362
RxNorm name
ponatinib 45 MG Oral Tablet [Iclusig]
Display name
ponatinib 45 MG Oral Tablet [Iclusig]
Full name
ponatinib 45 MG Oral Tablet [Iclusig]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

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
IclusigPONATINIB HYDROCHLORIDETakeda Pharmaceuticals America, Inc.16d804b6-4957-43ee-b18c-3b36ec37c5ac2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1364362

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
16d804b6-4957-43ee-b18c-3b36ec37c5acIclusig 45 MG Oral Tablet [PSN] · ponatinib 45 MG Oral Tablet [Iclusig] [SBD] · Iclusig (as ponatinib hydrochloride) 45 MG Oral Tablet [SY] · Iclusig 45 MG Oral Tablet [SY]419These highlights do not include all the information needed to use ICLUSIG safely and effectively. See full prescribing information for ICLUSIG. ICLUSIG ® (ponatinib) tablets, for oral use Initial U.S. Approval: 201220260429