Cipla Limited
Raigad, India · makes it, tests it, packages it and labels it
Problems found, fixed voluntarily Last FDA inspection Apr 4, 2024. 7 inspections on record.
NDC 53002-1192
Sertraline Hydrochloride 50 mg tablet
On the label: RPK Pharmaceuticals, Inc..
It's a repackaged product: RPK Pharmaceuticals, Inc. rebottles it from Cipla USA., Inc.'s NDC 69097-834.
Where the pills inside were made
Cipla Limited
Pune, India · makes it, tests it, packages it and labels it
Problems found, fixed voluntarily Last FDA inspection May 8, 2024. 7 inspections on record.
InvaGen Pharmaceuticals, Inc
Hauppauge, NY, United States · makes it and tests it
No problems found Last FDA inspection Oct 25, 2023. 18 inspections on record.
InvaGen Pharmaceuticals, Inc
Central Islip, NY, United States · makes it, tests it and packages it
Problems found, fixed voluntarily Last FDA inspection Jul 17, 2026. 4 inspections on record.
Repackaging site
- RPK Pharmaceuticals, Inc., · repackages it and relabels it
Product details
- Generic drug
- Sertraline: see every company that makes it
- Form
- tablet
- Strength
- 50 mg
- Approval
- ANDA ANDA077397
- On the market since
- Jul 21, 2016
- Package NDCs
53002-1192-053002-1192-153002-1192-353002-1192-6- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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