NDC 70436-123
gadoterate meglumine 376.9 mg per 1 mL injection
On the label: Slate Run Pharmaceuticals, LLC..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Anhui Poly Pharm. Co., Ltd. | Anqing, China | Makes the active ingredient | Problems found, fixed voluntarilyFeb 27, 2025 · 1 inspection |
| Hainan Poly Pharm. Co., Ltd. | Haikou, China | Makes it | Problems found, fixed voluntarilyJun 30, 2023 · 4 inspections |
Product details
- Generic drug
- Gadolinium Cation (3+): every company that makes it
- Form
- injection, intravenous
- Strength
- 376.9 mg per 1 mL
- Approval
- ANDA ANDA218073
- On the market since
- Jun 28, 2024
- Package NDCs
70436-123-3170436-123-3370436-123-3470436-123-35- Official label
- DailyMed (National Library of Medicine), updated Apr 16, 2025
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