Quick answers
- What is Procysbi?
- Procysbi is a brand name of Cysteamine bitartrate, a prescription medicine. The FDA NDC Directory lists 4 Procysbi products in 4 strengths and forms.
- Who makes Procysbi?
- Horizon holds the FDA application for Procysbi (NDA203389, approved April 30, 2013).
- Is there a generic or store brand of Procysbi?
- Other products of Cysteamine bitartrate are listed with the FDA, but none in exactly the same strength and form as a Procysbi product.
- Has Procysbi been recalled?
- No recall linked to Procysbi products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Procysbi is
Each Procysbi 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.
Cysteamine bitartrate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cysteamine bitartrate 25 mg capsule, delayed release pellets (oral) | Procysbi | None listed | DailyMed |
| cysteamine bitartrate 300 mg granule, delayed release (oral) | Procysbi | None listed | DailyMed |
| cysteamine bitartrate 75 mg capsule, delayed release pellets (oral) | Procysbi | None listed | DailyMed |
| cysteamine bitartrate 75 mg granule, delayed release (oral) | Procysbi | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Cysteamine bitartrate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Procysbi
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Procysbi products.
- Horizon Therapeutics USA, Inc.4 products
Recalls
No recall linked to Procysbi 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.