Quick answers
- What is Iodixanol used for?
- The FDA-approved label (Visipaque, GE Healthcare Inc., October 17, 2025) says: “VISIPAQUE is indicated for: VISIPAQUE injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iodixanol have a boxed warning?
- Yes. The FDA label for Visipaque has a boxed warning (“WARNING: NOT FOR INTRATHECAL USE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Iodixanol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Iodixanol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Iodixanol?
- 2 companies list prescription products of Iodixanol in the FDA NDC Directory, including GE Healthcare Inc. and Fresenius Kabi USA, LLC.
What Iodixanol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VISIPAQUE is indicated for: VISIPAQUE injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL). …
— FDA label: Visipaque, GE Healthcare Inc., effective October 17, 2025. Read the full label on DailyMed →
The FDA has 3 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: NOT FOR INTRATHECAL USE
. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravascular |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Visipaque |
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.
- GE Healthcare Inc.3 products
- Fresenius Kabi USA, LLC2 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 |
|---|---|---|---|
| NDA020351 VISIPAQUE 270, VISIPAQUE 320 | Ge Healthcare | March 22, 1996 | 25, latest April 25, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
| NDA020808 VISIPAQUE 270, VISIPAQUE 320 | Ge Healthcare | August 29, 1997 | 10, latest April 25, 2023 2023: Labeling · 2022: Labeling · 2019: Labeling |
Generic approvals (1)
- ANDA214271Hengrui Pharma · May 19, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 2d964c13-88ad-43be-88d4-a3a7ea4d5b5e |
|---|---|
| FDA labels (SPL) | 3 |
| FDA applications | NDA020351, NDA020808, 1 ANDA |
| Active ingredients (FDA) | IODIXANOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Visipaque, GE Healthcare Inc., effective October 17, 2025; 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 →