NDC 67046-638
Quetiapine fumarate 300 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from BluePoint Laboratories.'s NDC 68001-183.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Pithampur, India | Makes it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Product details
- Generic drug
- Quetiapine: every company that makes it
- Form
- tablet
- Strength
- 300 mg
- Approval
- ANDA ANDA201109
- On the market since
- Sep 26, 2017
- Package NDCs
67046-638-0767046-638-1467046-638-1567046-638-2067046-638-2167046-638-2867046-638-3067046-638-60- Official label
- DailyMed (National Library of Medicine), updated Sep 26, 2017
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