NDC 67046-622
Quetiapine 300 mg tablet, film coated
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-149.
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 |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 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, film coated
- Strength
- 300 mg
- Approval
- ANDA ANDA202152
- On the market since
- Sep 26, 2017
- Package NDCs
67046-622-0767046-622-1467046-622-1567046-622-2067046-622-2167046-622-2867046-622-3067046-622-60- Official label
- DailyMed (National Library of Medicine), updated Sep 26, 2017
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