NDC 50419-331
Ambelvist 257.9 mg per 1 mL injection
On the label: Bayer HealthCare Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bayer AG | Berlin, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 6, 2024 · 9 inspections |
| Bayer AG | Bergkamen, Germany | Makes the active ingredient and tests it | Problems found, fixed voluntarilyNov 14, 2024 · 7 inspections, 1 with FDA action |
| Malladi Drugs and Pharmaceuticals Limited | Chittoor, India | Makes the active ingredient | No problems foundJul 3, 2026 · 5 inspections |
| NUVISAN GmbH | Waltrop, Germany | Tests it | Problems found, fixed voluntarilyJan 16, 2025 · 3 inspections |
| Nuvisan France SARL | Biot, France | Tests it | Not inspected on record |
| Sharp Packaging Services, LLC | Macungie, PA, United States | Labels it | Problems found, fixed voluntarilySep 12, 2025 · 6 inspections |
Product details
- Generic drug
- Gadoquatrane: every company that makes it
- Form
- injection, intravenous
- Strength
- 257.9 mg per 1 mL
- Approval
- NDA NDA219627
- On the market since
- Jun 12, 2026
- Package NDCs
50419-331-0150419-331-11- Official label
- DailyMed (National Library of Medicine), updated Jun 12, 2025
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