Quick answers
- What is Isovue 300?
- Isovue 300 is a brand name of Iopamidol, a prescription medicine. The FDA NDC Directory lists 1 Isovue 300 product in 1 strength and form.
- Who makes Isovue 300?
- Bracco holds the FDA application for Isovue 300 (NDA018735, approved December 31, 1985).
- Is there a generic or store brand of Isovue 300?
- Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Isovue 300 product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Isovue 300 been recalled?
- FDA enforcement reports list 1 recall of Isovue 300 products; the newest started November 21, 2012. A recall usually concerns specific lots, not every product.
What Isovue 300 is
Each Isovue 300 product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Iopamidol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| iopamidol 612 mg/mL injection, solution (intravascular) | Isovue 300 | 3 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Iopamidol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018735 | Bracco | December 31, 1985 | 1 |
Companies that list Isovue 300
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Isovue 300 products.
- Bracco Diagnostics Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 21, 2012 · Class I · Terminated · D-158-2013
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67. — Bracco Diagnostic Inc
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.