NDC 61919-764
Simvastatin 80 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-465.
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
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Simvastatin: every company that makes it
- Form
- tablet, film coated
- Strength
- 80 mg
- Approval
- ANDA ANDA078103
- On the market since
- Jan 18, 2021
- Package NDCs
61919-764-90- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2023
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