NDC 53002-4192
Sertraline Hydrochloride 50 mg tablet, film coated
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-216.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Product details
- Generic drug
- Sertraline: every company that makes it
- Form
- tablet, film coated
- Strength
- 50 mg
- Approval
- ANDA ANDA202825
- On the market since
- Feb 9, 2017
- Package NDCs
53002-4192-053002-4192-153002-4192-353002-4192-6- Official label
- DailyMed (National Library of Medicine), updated Aug 18, 2023
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