NDC 61919-418
Glyburide And Metformin Hydrochloride 5 mg / 500 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-082.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Glyburide and Metformin: every company that makes it
- Form
- tablet, film coated
- Strength
- 5 mg / 500 mg
- Approval
- ANDA ANDA077870
- On the market since
- Dec 3, 2015
- Package NDCs
61919-418-60- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2020
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