Quick answers
- What is Iopamidol used for?
- The FDA-approved label (Isovue-M, Bracco Diagnostics Inc, February 10, 2026) says: “ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure […]. ISOVUE-M is a radiographic contrast agent indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iopamidol have a boxed warning?
- The label we quote has no boxed warning, but 3 of 5 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Iopamidol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Iopamidol been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 21, 2012 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Iopamidol?
- 2 companies list prescription products of Iopamidol in the FDA NDC Directory, including Bracco Diagnostics Inc and Slate Run Pharmaceuticals, LLC.
What Iopamidol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure […]. ISOVUE-M is a radiographic contrast agent indicated for …
— FDA label: Isovue-M, Bracco Diagnostics Inc, effective February 10, 2026. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
3 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravascular · Intrathecal |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Isovue-M, Isovue 370, Isovue 300, Isovue 200, Isovue 250 |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bracco Diagnostics Inc8 products
- Slate Run Pharmaceuticals, LLC6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018735 ISOVUE-128, ISOVUE-200, ISOVUE-250, ISOVUE-300, ISOVUE-370, ISOVUE-M 200 | Bracco | December 31, 1985 | 55, latest January 13, 2026 2026: Labeling · 2025: Labeling · 2025: Efficacy |
| NDA020327 ISOVUE-200, ISOVUE-250, ISOVUE-300, ISOVUE-370 | Bracco | October 12, 1994 | 14, latest January 13, 2026 2026: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (2)
- ANDA215382Hainan Poly · February 27, 2023
- ANDA217134Hainan Poly · September 27, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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-157-2013
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Pr — Bracco Diagnostic Inc
-
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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | 11e893d2-0183-4581-b908-c8b7302c7edb |
|---|---|
| FDA labels (SPL) | 5 |
| FDA applications | NDA018735, NDA020327, 2 ANDA |
| Active ingredients (FDA) | IOPAMIDOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Isovue-M, Bracco Diagnostics Inc, effective February 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →