FDA.reportPublic FDA data

mitapivat 100 MG (as mitapivat sulfate 117 MG) Oral Tablet

RxCUI
2730660
RxNorm name
mitapivat 100 MG (as mitapivat sulfate 117 MG) Oral Tablet
Display name
mitapivat 100 MG (as mitapivat sulfate 117 MG) Oral Tablet
Full name
mitapivat 100 MG (as mitapivat sulfate 117 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

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
AQVESMEMITAPIVATAgios Pharmaceuticals, Inc.1d4e2654-1636-0d01-e063-6394a90af3032026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2730660

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
1d4e2654-1636-0d01-e063-6394a90af303mitapivat 100 MG Oral Tablet [PSN] · mitapivat 100 MG Oral Tablet [SCD] · mitapivat 100 MG (as mitapivat sulfate 117 MG) Oral Tablet [SY]34These highlights do not include all the information needed to use AQVESME safely and effectively. See full prescribing information for AQVESME . AQVESME ™ ( mitapivat ) tablets for oral use Initial U.S. Approval: 202220260422