NDC 72189-366
Quetiapine Fumarate 50 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-249.
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
- Direct Rx, Dawsonville, GA, 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
- 50 mg
- Approval
- ANDA ANDA201504
- On the market since
- Jul 27, 2022
- Package NDCs
72189-366-3072189-366-60- Official label
- DailyMed (National Library of Medicine), updated Jun 16, 2025
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