NDC 72189-483
Quetiapine Fumarate ER 400 mg tablet, extended release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Accord Healthcare Inc.'s NDC 16729-097.
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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Quetiapine: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 400 mg
- Approval
- ANDA ANDA090681
- On the market since
- Jun 1, 2023
- Package NDCs
72189-483-30- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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