NDC 52584-411
Isovue-M 200 408 mg per 1 mL injection, solution
On the label: General Injectables & Vaccines, Inc.. It's repackaged: General Injectables & Vaccines, Inc. rebottles it from Bracco Diagnostics Inc.'s NDC 0270-1411.
Where the pills inside were 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 |
| Patheon Italia S.p.A | Ferentino, Italy | Makes it and tests it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections, 1 with FDA action |
| BioChem Labor für biologische und chemische Analytik GmbH | Karlsruhe, Germany | Tests it | No problems foundMar 23, 2022 · 4 inspections |
| Labor LS SE & Co. KG | Bad Bocklet, Germany | Tests it | Problems found, fixed voluntarilyDec 14, 2022 · 6 inspections, 1 with FDA action |
Repackaging site
- General Injectables & Vaccines, Inc., Location not on file · relabels it
Product details
- Generic drug
- Iopamidol: every company that makes it
- Form
- injection, solution
- Strength
- 408 mg per 1 mL
- Approval
- NDA NDA018735
- On the market since
- Nov 5, 2010
- Package NDCs
52584-411-11- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2017
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