Quick answers
- What is Orfadin?
- Orfadin is a brand name of Nitisinone, a prescription medicine. The FDA NDC Directory lists 5 Orfadin products in 5 strengths and forms.
- Who makes Orfadin?
- Swedish Orphan holds the FDA application for Orfadin (NDA021232, approved January 18, 2002).
- Is there a generic or store brand of Orfadin?
- Yes. The FDA NDC Directory lists 14 other products with the same active ingredients, strength and form as a Orfadin product, 14 of them generic. Ask your pharmacist whether one is right for you.
- Has Orfadin been recalled?
- No recall linked to Orfadin products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Orfadin is
Each Orfadin 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.
Nitisinone · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nitisinone 10 mg capsule (oral) | Orfadin | 4 products, 4 companies | DailyMed |
| nitisinone 2 mg capsule (oral) | Orfadin | 4 products, 4 companies | DailyMed |
| nitisinone 20 mg capsule (oral) | Orfadin | 2 products, 2 companies | DailyMed |
| nitisinone 4 mg/mL suspension (oral) | Orfadin | None listed | DailyMed |
| nitisinone 5 mg capsule (oral) | Orfadin | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nitisinone →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Orfadin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Orfadin products.
- Swedish Orphan Biovitrum Ab (Publ)5 products
Recalls
No recall linked to Orfadin 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.