Quick answers
- What is Malarone?
- Malarone is a brand name of Atovaquone and proguanil hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Malarone products in 2 strengths and forms.
- Who makes Malarone?
- Glaxosmithkline holds the FDA application for Malarone (NDA021078, approved July 14, 2000).
- Is there a generic or store brand of Malarone?
- Yes. The FDA NDC Directory lists 11 other products with the same active ingredients, strength and form as a Malarone product, 11 of them generic. Ask your pharmacist whether one is right for you.
- Has Malarone been recalled?
- No recall linked to Malarone products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Malarone is
Each Malarone 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.
Atovaquone and proguanil hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| atovaquone 250 mg · proguanil hydrochloride 100 mg tablet, film coated (oral) | Malarone | 9 products, 8 companies | DailyMed |
| atovaquone 62.5 mg · proguanil hydrochloride 25 mg tablet, film coated (oral) | Malarone | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Atovaquone and proguanil hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021078 | Glaxosmithkline | July 14, 2000 | 2 |
Companies that list Malarone
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Malarone products.
- GlaxoSmithKline LLC2 products
Recalls
No recall linked to Malarone 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.