TEPOTINIB HYDROCHLORIDE - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2021-06-25
Label type: Indexing - product concept
Version: 1
Source: full-release
Hydrated at: 2026-06-05 00:19:45

Label at a glance#

ProductTEPOTINIB HYDROCHLORIDE

Active ingredientTEPOTINIB HYDROCHLORIDE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

TEPOTINIB HYDROCHLORIDE
TEPOTINIB

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TEPOTINIB HYDROCHLORIDE	VY5YX2TQ1F	ACTIM

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEPMETKO	TEPOTINIB HYDROCHLORIDE	EMD Serono, Inc.	80a0f1b9-071a-47f5-9e67-32d638a669dc	2025-04-17	Warnings, Adverse reactions	Name fallback generic name: TEPOTINIB HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.