NDC 61919-642
Tobramycin 3 mg per 1 mL solution/ drops
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Somerset Therapeutics, LLC's NDC 70069-131.
Where the pills inside were made
| Factory | Where | Role | Last FDA 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
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Tobramycin: every company that makes it
- Form
- solution/ drops, ophthalmic
- Strength
- 3 mg per 1 mL
- Approval
- ANDA ANDA207444
- On the market since
- Apr 23, 2019
- Package NDCs
61919-642-05- Official label
- DailyMed (National Library of Medicine), updated Jan 10, 2024
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