FDA.reportPublic FDA data

avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-Pack

RxCUI
2714921
RxNorm name
avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-Pack
Display name
avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-Pack
Full name
avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-Pack
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

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
AVMAPKI FAKZYNJA CO-PACKAVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDEVerastem Inc.65889527-1406-45df-8a85-e2690dcf427d2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 2714921

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-e2690dcf427d{24 (avutometinib 0.8 MG Oral Capsule) / 42 (defactinib 200 MG Oral Tablet) } Pack [GPCK] · avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-Pack [PSN] · avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-Pack [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