NDC 54868-3086
Multaq 400 mg tablet, film coated
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Sanofi-Aventis U.S. LLC's NDC 0024-4142.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sanofi Winthrop Industrie | Ambares Et Lagrave, France | Makes it and tests it | Problems found, fixed voluntarilyNov 22, 2023 · 5 inspections |
| Sanofi Winthrop Industrie | Sisteron, France | Makes the active ingredient and tests it | Problems found, fixed voluntarilySep 15, 2023 · 6 inspections |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| Sanofi Winthrop Industrie | Tours, France | Packages it and labels it | Problems found, fixed voluntarilyJan 27, 2023 · 6 inspections |
Product details
- Generic drug
- Dronedarone: every company that makes it
- Form
- tablet, film coated
- Strength
- 400 mg
- Approval
- NDA NDA022425
- On the market since
- Feb 23, 2010
- Package NDCs
54868-3086-0- Official label
- DailyMed (National Library of Medicine), updated Dec 28, 2011
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