Quick answers
- What is Iopromide used for?
- The FDA-approved label (Ultravist, Bayer HealthCare Pharmaceuticals Inc., March 2, 2026) says: “ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iopromide have a boxed warning?
- Yes. The FDA label for Ultravist has a boxed warning (“WARNING: NOT FOR INTRATHECAL USE 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 Iopromide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Iopromide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Iopromide?
- 1 company lists prescription products of Iopromide in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc..
What Iopromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years …
— FDA label: Ultravist, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026. Read the full label on DailyMed →
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.
This label has a boxed warning. Its heading: WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intra-arterial · Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Ultravist |
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.
- Bayer HealthCare Pharmaceuticals Inc.4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020220 ULTRAVIST 150, ULTRAVIST 240, ULTRAVIST 300, ULTRAVIST 300 IN PLASTIC CONTAINER, ULTRAVIST 370 | Bayer Hlthcare | May 10, 1995 | 30, latest June 15, 2023 2023: Labeling · 2023: Efficacy · 2023: Labeling |
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 | df917c3a-59a2-4ed1-8470-8a5394c73325 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA020220 |
| Active ingredients (FDA) | IOPROMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ultravist, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 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 →