NDC 72189-446
Quetiapine Fumarate 25 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-242.
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
- 25 mg
- Approval
- ANDA ANDA201504
- On the market since
- Mar 14, 2023
- Package NDCs
72189-446-3072189-446-60- Official label
- DailyMed (National Library of Medicine), updated Mar 5, 2026
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