NDC 67046-0628
Simvastatin 40 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-464.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Product details
- Generic drug
- Simvastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA078103
- On the market since
- May 21, 2026
- Package NDCs
67046-0628-3- Official label
- DailyMed (National Library of Medicine), updated May 21, 2026
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