FDA.reportPublic FDA data

quizartinib 26.5 MG Oral Tablet [Vanflyta]

RxCUI
2643064
RxNorm name
quizartinib 26.5 MG Oral Tablet [Vanflyta]
Display name
quizartinib 26.5 MG Oral Tablet [Vanflyta]
Full name
quizartinib 26.5 MG Oral Tablet [Vanflyta]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

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
VANFLYTAQUIZARTINIBDaiichi Sankyo Inc.29cdbcfe-497d-4e78-bb7b-2d4acafe8e862026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2643064

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
29cdbcfe-497d-4e78-bb7b-2d4acafe8e86VANFLYTA 26.5 MG Oral Tablet [PSN] · quizartinib 26.5 MG Oral Tablet [Vanflyta] [SBD] · Vanflyta 26.5 MG (equivalent to 30 MG quizartinib dihydrochloride) Oral Tablet [SY] · Vanflyta 26.5 MG Oral Tablet [SY]411These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 202320260416