FDA.reportPublic FDA data

Avmapki 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral Capsule

RxCUI
2714526
RxNorm name
Avmapki 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral Capsule
Display name
Avmapki 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral Capsule
Full name
Avmapki 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVMAPKI FAKZYNJA CO-PACKAVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDEVerastem Inc.65889527-1406-45df-8a85-e2690dcf427d2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 2714526

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
65889527-1406-45df-8a85-e2690dcf427dAVMAPKI 0.8 MG Oral Capsule [PSN] · avutometinib 0.8 MG Oral Capsule [Avmapki] [SBD] · Avmapki 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral Capsule [SY]32These highlights do not include all the information needed to use AVMAPKI™ FAKZYNJA™ CO-PACK safely and effectively. See full prescribing information for AVMAPKI™ FAKZYNJA™ CO-PACK. AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets), co-packaged for oral use Initial U.S. Approval: 202520250501