NDC 67046-0487
Quetiapine 100 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Ascend Laboratories, LLC's NDC 67877-250.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it, tests it and packages it | No problems foundAug 30, 2019 · 6 inspections |
| Alkem Laboratories Limited | Baddi Solan, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Nov 14, 2018 · Class II · Ascend Laboratories LLC
Presence of Foreign Substance; metal shard found in tablet
Lots: Lot 7143908, exp Nov 2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Quetiapine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA201504
- On the market since
- Jul 7, 2026
- Package NDCs
67046-0487-3- Official label
- DailyMed (National Library of Medicine), updated Jul 7, 2026
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