NDC 76420-779
Sertraline Hydrochloride 25 mg tablet, film coated
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-011.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it
Product details
- Generic drug
- Sertraline: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 25 mg
- Approval
- ANDA ANDA077206
- On the market since
- Feb 6, 2007
- Package NDCs
76420-779-0176420-779-3076420-779-6076420-779-90- Official label
- DailyMed (National Library of Medicine), updated Feb 12, 2025
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