NDC 80425-0389
Duloxetine 60 mg capsule, delayed release
On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-296.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Repackaging site
- Advanced Rx Pharmacy of Tennessee, LLC, Nashville, TN, United States · repackages it
Recalls
- Nov 21, 2017 · Class III · Lupin Pharmaceuticals Inc.
Failed Dissolution Specification
Lots: Lot #: G602051, Exp. 12/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Duloxetine: every company that makes it
- Form
- capsule, delayed release, oral
- Strength
- 60 mg
- Approval
- ANDA ANDA090694
- On the market since
- May 22, 2024
- Package NDCs
80425-0389-180425-0389-280425-0389-3- Official label
- DailyMed (National Library of Medicine), updated Oct 22, 2024
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