NDC 80425-0235
Diclofenac Sodium 30 mg per 1 g gel
On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1363.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharma Canada Inc. | Brampton, Canada | Makes it | No problems foundMar 27, 2026 · 7 inspections |
Repackaging site
- Advanced Rx Pharmacy of Tennessee, LLC, Nashville, TN, United States · repackages it
Recalls
- Jan 27, 2026 · Class II · Sun Pharmaceutical Industries Inc
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Lots: Lot # AD92721, Exp Date: 3/31/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diclofenac: every company that makes it
- Form
- gel, topical
- Strength
- 30 mg per 1 g
- Approval
- ANDA ANDA206298
- On the market since
- Jan 10, 2023
- Package NDCs
80425-0235-1- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2024
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