NDC 80425-0168
Eszopiclone 1 mg tablet, film coated
On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-299.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
Repackaging site
- Advanced Rx Pharmacy of Tennessee, LLC, Nashville, TN, United States · repackages it
Recalls
- Jun 16, 2022 · Class II · Macleods Pharma Usa Inc
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Lots: Lot #: BEK2009A Exp: 11/2023
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, film coated, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA202929
- On the market since
- Jan 31, 2015
- Package NDCs
80425-0168-180425-0168-280425-0168-3- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2024
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