FDA.reportPublic FDA data

ensartinib 100 MG Oral Capsule [Ensacove]

RxCUI
2712640
RxNorm name
ensartinib 100 MG Oral Capsule [Ensacove]
Display name
ensartinib 100 MG Oral Capsule [Ensacove]
Full name
ensartinib 100 MG Oral Capsule [Ensacove]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

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
ENSACOVEENSARTINIBXcovery Holdings, Inc.1e1b2f79-678a-472a-b924-66909c8a4b2e2026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 2712640

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
1e1b2f79-678a-472a-b924-66909c8a4b2eEnsacove 100 MG Oral Capsule [PSN] · ensartinib 100 MG Oral Capsule [Ensacove] [SBD] · Ensacove 100 MG (as ensartinib hydrochloride 113 MG) Oral Capsule [SY]35These highlights do not include all the information needed to use ENSACOVE safely and effectively. See full prescribing information for ENSACOVE. ENSACOVE TM (ensartinib) capsules, for oral use Initial U.S. Approval: 202420260217