FDA.reportPublic FDA data

IDHIFA 50 MG Oral Tablet

RxCUI
1940376
RxNorm name
IDHIFA 50 MG Oral Tablet
Display name
IDHIFA 50 MG Oral Tablet
Full name
IDHIFA 50 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:12

RxNav Current And Historical NDCs#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IdhifaENASIDENIB MESYLATECelgene Corporationa5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b62025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1940376

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6IDHIFA 50 MG Oral TabletPSN12These highlights do not include all the information needed to use IDHIFA safely and effectively. See full prescribing information for IDHIFA. IDHIFA ® (enasidenib) tablets, for oral use Initial U.S. Approval: 201720250116
a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6Idhifa 50 MG (as enasidenib mesylate 60 MG) Oral TabletSY12These highlights do not include all the information needed to use IDHIFA safely and effectively. See full prescribing information for IDHIFA. IDHIFA ® (enasidenib) tablets, for oral use Initial U.S. Approval: 201720250116
a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6enasidenib 50 MG Oral Tablet [Idhifa]SBD12These highlights do not include all the information needed to use IDHIFA safely and effectively. See full prescribing information for IDHIFA. IDHIFA ® (enasidenib) tablets, for oral use Initial U.S. Approval: 201720250116