Lupin Limited
Salcette, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Nov 21, 2025. 9 inspections on record, 1 with serious problems.
NDC 33261-346
Sertraline 100 mg tablet, film coated
On the label: Aidarex Pharmaceuticals LLC.
It's a repackaged product: Aidarex Pharmaceuticals LLC rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-353.
Where the pills inside were made
Lupin Limited
Pithampur, India · makes it and packages it
Serious problems, FDA action Last FDA inspection Jul 17, 2025. 6 inspections on record, 4 with serious problems.
Lupin Limited
Chhatrapati Sambhajinagar, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Mar 15, 2024. 5 inspections on record.
Recalls
- Nov 5, 2025 · Class II · Ongoing
Defective container - seal not adhering to bottles
Lots: Lot # QB00865, exp. date Feb 2028
Product details
- Generic drug
- Sertraline: see every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg
- Approval
- ANDA ANDA077670
- On the market since
- Feb 6, 2007
- Package NDCs
33261-346-3033261-346-6033261-346-90- Official label
- DailyMed (National Library of Medicine), updated Jan 31, 2014
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