Quick answers
- What is Kuvan?
- Kuvan is a brand name of Sapropterin dihydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Kuvan products in 3 strengths and forms.
- Who makes Kuvan?
- Biomarin Pharm holds the FDA application for Kuvan (NDA022181, approved December 13, 2007).
- Is there a generic or store brand of Kuvan?
- Yes. The FDA NDC Directory lists 20 other products with the same active ingredients, strength and form as a Kuvan product, 20 of them generic. Ask your pharmacist whether one is right for you.
- Has Kuvan been recalled?
- No recall linked to Kuvan products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Kuvan is
Each Kuvan 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.
Sapropterin dihydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sapropterin dihydrochloride 100 mg powder, for solution (oral) | Kuvan | 7 products, 7 companies | DailyMed |
| sapropterin dihydrochloride 100 mg tablet (oral) | Kuvan | 6 products, 6 companies | DailyMed |
| sapropterin dihydrochloride 500 mg powder, for solution (oral) | Kuvan | 7 products, 7 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sapropterin dihydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Kuvan
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Kuvan products.
- BioMarin Pharmaceutical Inc.3 products
Recalls
No recall linked to Kuvan 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.