NDC 72189-122
Sertraline Hydrochloride 100 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-013.
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
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Sertraline: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA077206
- On the market since
- Jul 29, 2020
- Package NDCs
72189-122-3072189-122-6072189-122-90- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2025
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