Quick answers
- What is Cuvrior?
- Cuvrior is a brand name of Trientine, a prescription medicine. The FDA NDC Directory lists 1 Cuvrior product in 1 strength and form.
- Who makes Cuvrior?
- Orphalan holds the FDA application for Cuvrior (NDA215760, approved April 28, 2022).
- Is there a generic or store brand of Cuvrior?
- Other products of Trientine are listed with the FDA, but none in exactly the same strength and form as a Cuvrior product.
- Has Cuvrior been recalled?
- No recall linked to Cuvrior products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Cuvrior is
Each Cuvrior 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.
Trientine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| trientine tetrahydrochloride 300 mg tablet, film coated (oral) | Cuvrior | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Trientine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA215760 | Orphalan | April 28, 2022 | 1 |
Companies that list Cuvrior
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Cuvrior products.
- Orphalan SA1 product
Recalls
No recall linked to Cuvrior 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.