Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Atovaquone

Brand names: Mepron

Drug class: Antimalarial, Antiprotozoal

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
3Recalls (FDA reports)
21Companies
1995First FDA approval on file

Quick answers

What is Atovaquone used for?
The FDA-approved label (Mepron, GlaxoSmithKline LLC, March 20, 2026) says: “MEPRON oral suspension is a quinone antimicrobial drug indicated for: • Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). • Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Atovaquone have a boxed warning?
No. None of the 22 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Atovaquone?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Atovaquone been recalled?
FDA enforcement reports list 3 recalls of products of this medicine; the newest started September 17, 2024 (Class I). A recall usually concerns specific lots, not every product.
Who makes Atovaquone?
21 companies list prescription products of Atovaquone in the FDA NDC Directory, including Atlantic Biologicals Corp., GlaxoSmithKline LLC and PAI Holdings, LLC dba PAI Pharma.

What Atovaquone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

MEPRON oral suspension is a quinone antimicrobial drug indicated for: • Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). • Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. Limitations of Use …

— FDA label: Mepron, GlaxoSmithKline LLC, effective March 20, 2026. Read the full label on DailyMed →

The FDA has 22 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.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Pneumonia

Related medical specialties

Infectious Disease

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 22 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsSuspension
RouteOral
Prescription products24 in the FDA NDC Directory
Brand namesMepron

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.

NADAC per unit for Atovaquone, by strength and form
Strength and formGeneric or brandPharmacies pay
atovaquone 750 mg/5 mL
suspension		 Generic $0.7561 per mL

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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020500
MEPRON		 Glaxosmithkline LLCFebruary 8, 1995 12, latest March 20, 2026
2026: Labeling · 2019: Labeling · 2019: Labeling

Generic approvals (7)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. September 17, 2024 · Class I · Terminated · D-0012-2025

    Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

    Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87. — Bionpharma Inc.

  2. March 13, 2023 · Class I · Ongoing · D-0567-2023

    Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

    Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, — Camber Pharmaceuticals Inc.

  3. July 2, 2021 · Class I · Terminated · D-0772-2021

    Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

    Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21. — KVK-Tech, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)211947, 308429
SPL set ID of the quoted labelb426b6bf-f07e-4580-97ae-dfca1ddf5b8f
FDA labels (SPL)22
FDA applicationsNDA020500, 7 ANDA
Active ingredients (FDA)ATOVAQUONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Mepron, GlaxoSmithKline LLC, effective March 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers