Quick answers
- What is Daraprim?
- Daraprim is a brand name of Pyrimethamine, a prescription medicine. The FDA NDC Directory lists 2 Daraprim products in 1 strength and form.
- Who makes Daraprim?
- Tilde Sciences holds the FDA application for Daraprim (NDA008578, approved January 23, 1953). 1 other company (repackagers or distributors) also list Daraprim products.
- Is there a generic or store brand of Daraprim?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Daraprim product, 4 of them generic. Ask your pharmacist whether one is right for you.
- Has Daraprim been recalled?
- No recall linked to Daraprim products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Daraprim is
Each Daraprim 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.
Pyrimethamine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pyrimethamine 25 mg tablet (oral) | Daraprim | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Pyrimethamine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA008578 | Tilde Sciences | January 23, 1953 | 2 |
Companies that list Daraprim
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Daraprim products.
- TILDE Sciences LLC1 product
- Vyera Pharmaceuticals LLC1 product
Recalls
No recall linked to Daraprim 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.