NDC 80425-0261
Dexamethasone Sodium Phosphate 10 mg per 1 mL injection
On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Somerset Therapeutics, LLC's NDC 70069-021.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Maiva Pharma Private Limited | Hosur, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 29, 2022 · 1 inspection |
| Somerset Therapeutics Private Limited | Bengaluru, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action |
Repackaging site
- Advanced Rx Pharmacy of Tennessee, LLC, Nashville, TN, United States · repackages it
Product details
- Generic drug
- Dexamethasone: every company that makes it
- Form
- injection, intramuscular; intravenous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA207442
- On the market since
- Feb 16, 2023
- Package NDCs
80425-0261-1- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2024
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