Quick answers
- What is ProHance?
- ProHance is a brand name of Gadoteridol, a prescription medicine. The FDA NDC Directory lists 1 ProHance product in 1 strength and form.
- Who makes ProHance?
- Bracco holds the FDA application for ProHance (NDA020131, approved November 16, 1992).
- Is there a generic or store brand of ProHance?
- Other products of Gadoteridol are listed with the FDA, but none in exactly the same strength and form as a ProHance product.
- Has ProHance been recalled?
- No recall linked to ProHance products (by their NDC code or label) appears in the FDA enforcement reports we use.
What ProHance is
Each ProHance 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.
Gadoteridol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| gadoteridol 279.3 mg/mL injection, solution (intravenous) | ProHance | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Gadoteridol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020131 | Bracco | November 16, 1992 | 1 |
Companies that list ProHance
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of ProHance products.
- Bracco Diagnostics Inc1 product
Recalls
No recall linked to ProHance products (by their NDC code or label) appears in the FDA enforcement reports.
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.