NDC 65219-080
Gadoterate Meglumine 376.9 mg per 1 mL injection
On the label: Fresenius Kabi USA, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) | Lianyungang, China | Makes it | Serious problems, FDA actionJan 16, 2024 · 5 inspections, 1 with FDA action |
Product details
- Generic drug
- Gadolinium Cation (3+): every company that makes it
- Form
- injection, intravenous
- Strength
- 376.9 mg per 1 mL
- Approval
- ANDA ANDA215304
- On the market since
- Jun 20, 2022
- Package NDCs
65219-080-0165219-080-05- Official label
- DailyMed (National Library of Medicine), updated Nov 6, 2025
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