NDC 67046-1452
Amantadine Hydrochloride 100 mg tablet
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Vensun Pharmaceuticals, Inc.'s NDC 42543-497.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Strides Pharma Science Limited | Chengalpattu, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 5, 2024 · 7 inspections |
| Strides Pharma Science Limited | Puducherry, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 24, 2023 · 2 inspections, 1 with FDA action |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Product details
- Generic drug
- Amantadine: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA209035
- On the market since
- Feb 7, 2025
- Package NDCs
67046-1452-3- Official label
- DailyMed (National Library of Medicine), updated Feb 7, 2025
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