NDC 53808-0586
Sertraline Hydrochloride 25 mg tablet, film coated
On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-351.
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 |
| Lupin Limited | Chhatrapati Sambhajinagar, India | Makes it and packages it | Problems found, fixed voluntarilyMar 15, 2024 · 5 inspections |
Recalls
- Nov 5, 2025 · Class II · Lupin Pharmaceuticals Inc.
Defective container - seal not adhering to bottles
Lots: Lot # QB00865, exp. date Feb 2028
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sertraline: every company that makes it
- Form
- tablet, film coated
- Strength
- 25 mg
- Approval
- ANDA ANDA077670
- On the market since
- Jul 1, 2009
- Package NDCs
53808-0586-1- Official label
- DailyMed (National Library of Medicine), updated Jun 8, 2010
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