NDC 61919-378
Glyburide 5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.'s NDC 23155-058.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| USV Private Limited | Daman, India | Makes it | Serious problems, FDA actionApr 17, 2026 · 8 inspections, 3 with FDA action |
| USV Private Limited | Ratnagiri, India | Makes the active ingredient | Problems found, fixed voluntarilySep 12, 2025 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Glyburide: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA090937
- On the market since
- Dec 3, 2015
- Package NDCs
61919-378-60- Official label
- DailyMed (National Library of Medicine), updated Dec 4, 2015
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