Quick answers
- What is Atovaquone and proguanil hydrochloride used for?
- The FDA-approved label (Malarone, GlaxoSmithKline LLC, June 10, 2026) says: “MALARONE is an antimalarial indicated for: • prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. • treatment of acute, uncomplicated P. falciparum malaria. 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Atovaquone and proguanil hydrochloride have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Atovaquone and proguanil hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Atovaquone and proguanil hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Atovaquone and proguanil hydrochloride?
- 9 companies list prescription products of Atovaquone and proguanil hydrochloride in the FDA NDC Directory, including Mylan Pharmaceuticals Inc., A-S Medication Solutions and GlaxoSmithKline LLC.
What Atovaquone and proguanil hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MALARONE is an antimalarial indicated for: • prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. • treatment of acute, uncomplicated P. falciparum malaria. 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. …
— FDA label: Malarone, GlaxoSmithKline LLC, effective June 10, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Malarone |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| atovaquone 250 mg · proguanil hydrochloride 100 mg tablet, film coated | Generic | $1.45 per tablet |
| atovaquone 62.5 mg · proguanil hydrochloride 25 mg tablet, film coated | Generic | $0.8880 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mylan Pharmaceuticals Inc.2 products
- A-S Medication Solutions2 products
- GlaxoSmithKline LLC2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Bryant Ranch Prepack1 product
- Proficient Rx LP1 product
- Golden State Medical Supply, Inc.1 product
- Prasco Laboratories1 product
- BluePoint Laboratories1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021078 MALARONE, MALARONE PEDIATRIC | Glaxosmithkline | July 14, 2000 | 17, latest June 10, 2026 2026: Labeling · 2026: Labeling · 2019: Labeling |
Generic approvals (2)
- ANDA091211Glenmark Pharms Ltd · January 12, 2011
- ANDA202362Mylan · May 27, 2014
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 864675, 864679, 864681, 864685 |
|---|---|
| SPL set ID of the quoted label | fc22e8d8-3bfb-4f70-a599-dd81262a4887 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA021078, 2 ANDA |
| Active ingredients (FDA) | ATOVAQUONE / PROGUANIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Malarone, GlaxoSmithKline LLC, effective June 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →