NDC 71610-957
Duloxetine 20 mg capsule, delayed release
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-294.
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
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, 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
- 20 mg
- Approval
- ANDA ANDA090694
- On the market since
- Dec 11, 2013
- Package NDCs
71610-957-74- Official label
- DailyMed (National Library of Medicine), updated Oct 22, 2025
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