Quick answers
- What is Gadoquatrane used for?
- The FDA-approved label (Ambelvist, Bayer HealthCare Pharmaceuticals Inc., June 12, 2025) says: “AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gadoquatrane have a boxed warning?
- Yes. The FDA label for Ambelvist has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Gadoquatrane?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gadoquatrane been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gadoquatrane?
- 1 company lists prescription products of Gadoquatrane in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc..
What Gadoquatrane is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric …
— FDA label: Ambelvist, Bayer HealthCare Pharmaceuticals Inc., effective June 12, 2025. 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. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Ambelvist |
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.11 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA219627 AMBELVIST | Bayer Healthcare | June 12, 2026 | — |
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 | fac80f5d-8d37-4237-bb52-0faef0dd46aa |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA219627 |
| Active ingredients (FDA) | GADOQUATRANE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ambelvist, Bayer HealthCare Pharmaceuticals Inc., effective June 12, 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 →