FDA.reportPublic FDA data

Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet

RxCUI
2477272
RxNorm name
Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet
Display name
Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet
Full name
Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

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
TEPMETKOTEPOTINIB HYDROCHLORIDEEMD Serono, Inc.80a0f1b9-071a-47f5-9e67-32d638a669dc2025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 2477272

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
80a0f1b9-071a-47f5-9e67-32d638a669dcTEPMETKO 225 MG Oral Tablet [PSN] · tepotinib 225 MG Oral Tablet [Tepmetko] [SBD] · Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet [SY] · Tepmetko 225 MG Oral Tablet [SY]48These highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 202120250417