Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| BIPSO GmbH | Singen (Hohentwiel), Germany | Makes it and tests it | Problems found, fixed voluntarilyMay 4, 2022 · 5 inspections |
| Bracco Imaging Spa | Ceriano Laghetto, Italy | Makes the active ingredient | Problems found, fixed voluntarilyOct 28, 2022 · 3 inspections |
| BioChem Labor für biologische und chemische Analytik GmbH | Karlsruhe, Germany | Tests it | No problems foundMar 23, 2022 · 4 inspections |
| Bracco Imaging Spa | Colleretto Giacosa, Italy | Tests it | Problems found, fixed voluntarilyNov 27, 2025 · 2 inspections |
| Labor LS SE & Co. KG | Bad Bocklet, Germany | Tests it | Problems found, fixed voluntarilyDec 14, 2022 · 6 inspections, 1 with FDA action |
Product details
- Generic drug
- Gadoteridol: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 279.3 mg per 1 mL
- Approval
- NDA NDA020131
- On the market since
- Nov 16, 1992
- Package NDCs
0270-1111-010270-1111-020270-1111-030270-1111-04- Official label
- DailyMed (National Library of Medicine), updated Mar 14, 2025
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