NDC 53217-307
Eszopiclone 2 mg tablet, coated
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-619.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Recalls
- Jun 4, 2024 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: Related Substances
Lots: Lot#: C2302598, Exp 2/29/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Eszopiclone: every company that makes it
- Form
- tablet, coated
- Strength
- 2 mg
- Approval
- ANDA ANDA091024
- On the market since
- Apr 15, 2014
- Package NDCs
53217-307-3053217-307-60- Official label
- DailyMed (National Library of Medicine), updated Jun 30, 2017
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