NDC 58468-0211

Aubagio 7 mg tablet, film coated

On the label: Genzyme Corporation.

France: 2Switzerland: 1United Kingdom: 1Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Euroapi FranceVertolaye, FranceMakes the active ingredient No problems foundMar 8, 2024 · 8 inspections
Micro-Macinazione SaMonteggio, SwitzerlandMakes the active ingredient Problems found, fixed voluntarilyNov 13, 2024 · 6 inspections
Opella Healthcare International SasCompiegne, FranceMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyJan 10, 2025 · 6 inspections
Penn Pharmaceutical Services LimitedTredegar, United KingdomMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyApr 1, 2022 · 6 inspections
Sanofi-Aventis Deutschland GmbHFrankfurt am Main, GermanyMakes the active ingredient and tests it Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action
AndersonBrecon Inc.Rockford, IL, United StatesPackages it and labels it No problems foundAug 19, 2026 · 11 inspections

Product details

Generic drug
Teriflunomide: every company that makes it
Form
tablet, film coated, oral
Strength
7 mg
Approval
NDA NDA202992
On the market since
May 1, 2013
Package NDCs
58468-0211-1 58468-0211-2 58468-0211-3 58468-0211-4
Official label
DailyMed (National Library of Medicine), updated Feb 20, 2026

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