NDC 67046-1483
Sertraline hydrochloride 50 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Granules Pharmaceuticals Inc.'s NDC 70010-204.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Granules India Limited | Medchal-Malkajgiri District, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 14, 2020 · 6 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Product details
- Generic drug
- Sertraline: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA078403
- On the market since
- Jan 29, 2025
- Package NDCs
67046-1483-3- Official label
- DailyMed (National Library of Medicine), updated Jan 29, 2025
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