NDC 0955-3900
Insulin glargine U-300 300 [iU] per 1 mL injection, solution
On the label: Sanofi-Aventis U.S. LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis Deutschland GmbH | Frankfurt am Main, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
Product details
- Generic drug
- Insulin Glargine: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 300 [iU] per 1 mL
- Approval
- BLA BLA206538
- On the market since
- Apr 1, 2023
- Package NDCs
0955-3900-010955-3900-03- Official label
- DailyMed (National Library of Medicine), updated May 30, 2025
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