FDA.reportPublic FDA data

gilteritinib 40 MG Oral Tablet

RxCUI
2105811
RxNorm name
gilteritinib 40 MG Oral Tablet
Display name
gilteritinib 40 MG Oral Tablet
Full name
gilteritinib 40 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

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
XospataGILTERITINIBAstellas Pharma US, Inc.b5ff59aa-9c0d-49a8-9053-1f179b4823832022-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2105811

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
b5ff59aa-9c0d-49a8-9053-1f179b482383gilteritinib 40 MG Oral Tablet [PSN] · gilteritinib 40 MG Oral Tablet [SCD] · gilteritinib (as gilteritinib fumarate 44.2 MG) 40 MG Oral Tablet [SY]310These highlights do not include all the information needed to use XOSPATA safely and effectively. See full prescribing information for XOSPATA. XOSPATA ® (gilteritinib) tablets, for oral use Initial U.S. Approval: 201820220101