NDC 72189-477
Quetiapine Fumarate 400 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Rising Pharma Holdings, Inc.'s NDC 16571-722.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Quetiapine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 400 mg
- Approval
- ANDA ANDA091388
- On the market since
- May 30, 2023
- Package NDCs
72189-477-30- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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