NDC 43353-812
Sertraline 25 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Exelan Pharmaceuticals, Inc.'s NDC 76282-212.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ascent Pharmaceuticals Inc | Central Islip, NY, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyAug 9, 2024 · 9 inspections |
| InvaGen Pharmaceuticals, Inc | Hauppauge, NY, United States | Makes it and tests it | No problems foundOct 25, 2023 · 18 inspections |
| InvaGen Pharmaceuticals, Inc | Central Islip, NY, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyJul 17, 2026 · 4 inspections |
| Legacy Pharmaceutical Packaging | Location not on file | Packages it | Not inspected on record |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Sertraline: every company that makes it
- Form
- tablet, film coated
- Strength
- 25 mg
- Approval
- ANDA ANDA077397
- On the market since
- Aug 20, 2012
- Package NDCs
43353-812-30- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2019
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