NDC 50419-325
Gadavist 604.72 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, makes the active ingredient, tests it, packages it, labels it and sterilizes 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 |
| Dynamit Nobel GmbH Explosivstoff- und Systemtechnik | Leverkusen, Germany | Makes the active ingredient | Problems found, fixed voluntarilySep 1, 2023 · 5 inspections |
| Currenta GmbH & Co. OHG | Leverkusen, Germany | Tests it | Problems found, fixed voluntarilyFeb 15, 2023 · 3 inspections |
| Quality Packaging Specialists International, LLC | Burlington, NJ, United States | Labels it | No problems foundMay 12, 2023 · 6 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Labels it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Gadolinium Cation (3+): every company that makes it
- Form
- injection, intravenous
- Strength
- 604.72 mg per 1 mL
- Approval
- NDA NDA201277
- On the market since
- Mar 14, 2011
- Package NDCs
50419-325-1850419-325-1950419-325-7350419-325-74- Official label
- DailyMed (National Library of Medicine), updated Sep 11, 2026
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