Home › NDC Lookup › Ingredients › Atovaquone › 00173-0547-00
🧴image loading
(from DailyMed)

MEPRON atovaquone 750 mg/5mL Suspension — NDC 0173-0547-00 (Billing 00173-0547-00)

by GlaxoSmithKline LLC · 42 POUCH in 1 DOSE PACK / 5 mL in 1 POUCH

This is a package of MEPRON atovaquone 750 mg/5mL Suspension from GlaxoSmithKline LLC, marketed since Sep 1998 and currently FDA-listed. It is this product's only package size.

NDC 00173-0547-00
🏷️ FDA NDC (as labeled) 0173-0547-00 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Atovaquone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Mar 13, 2023 — Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product. (Camber Pharmaceuticals Inc.) · FDA recall D-0567-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0173-0547-00
Product NDC 0173-0547
11-digit billing NDC 00173054700
NCPDP billing unit ML — per mL (volume)
RxCUI 211947, 308429
UNII Y883P1Z2LT
Application # NDA020500
SPL Set ID b426b6bf-f07e-4580-97ae-dfca1ddf5b8f
Established class (EPC) Antimalarial; Antiprotozoal
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-09-18
Route ORAL
Dosage form SUSPENSION
Substance ATOVAQUONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 16400020001820
GCN Seq No 023399
GCN 34490
HICL code 006619
Ingredient (HICL) Atovaquone
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4K
Therapeutic class — specific (HIC3) Antiprotozoal Drugs,Miscellaneous
AHFS code 08:30.12.00
AHFS class Antiprotozoals, P Jirovecii Pneumonia
FDB label name MEPRON 750 MG/5 ML SUSPENSION
FDB brand name Mepron
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 023399
  • GCN: 34490
  • GPI-14 (Medi-Span): 16400020001820
  • HICL (First Databank): 006619
  • AHFS class code: 08:30.12.00
  • RxCUI (RxNorm): 211947
Why two NDCs? The FDA registers this code as 0173-0547-00 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00173-0547-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antimalarial class.

Pharmacologic class Antimalarial, Antiprotozoal
Drug family (ATC) Biguanides, Other agents against amoebiasis and other protozoal diseases
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MEPRON 750 MG/5 ML SUSPENSION Ingredient Atovaquone
📗 Our plain-language guide HelloPharmacist
  • Yes, it really matters — this is one of the most important things to know about atovaquone. Without food, your body absorbs roughly half as much of the medicine, which can mean blo...
  • Why do I have to take this medicine with food? Is it really that important?
  • PCP (Pneumocystis jirovecii pneumonia) is a serious lung infection caused by a fungal organism. It mainly affects people with weakened immune systems, such as those with HIV/AIDS....
  • What is PCP, and why am I being prescribed this instead of a more common antibiotic?
📖 Read our full Atovaquone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $7.50 $1,575.36 / 210 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00173-0547-00 You're viewing this Main listing 42 POUCH in 1 DOSE PACK / 5 mL in 1 POUCH 1998-09-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atovaquone 750 mg/5mL 70748-0299-01 Lupin 1 bottle $0.719 AB FDA listed —
Atovaquone 750 mg/5mL 00121-0956-08 PAI 1 bottle $0.767 AB Availability likely —
Atovaquone Oral Suspension 750 mg/5mL 10702-0223-21 KVK-Tech, 1 bottle $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 31722-0629-21 Camber 1 bottle $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 60687-0534-78 American 6 cups $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 62135-0528-09 Chartwell 210 ml $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 65162-0693-88 Amneal 1 bottle $0.767 AB Availability likely —
atovaquone 750 mg/5mL 68462-0421-21 Glenmark 210 ml $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 69452-0252-87 Bionpharma 1 bottle $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 72603-0248-01 NorthStar 1 bottle $0.767 AB Availability likely —
Atovaquone 750 mg/5mL 00121-1016-18 PAI 6 cups — AB FDA listed —
Mepron 750 mg/5mLthis 00173-0547-00 GlaxoSmithKline 42 pouches — AB FDA listed —
Mepron 750 mg/5mL 00173-0665-18 GlaxoSmithKline 210 ml — AB FDA listed —
Atovaquone 750 mg/5mL 00904-7459-25 Major 6 cups — AB FDA listed —
Atovaquone 750 mg/5mL 17856-0631-01 ATLANTIC 72 cups — AB FDA listed —
Atovaquone 750 mg/5mL 17856-8631-01 ATLANTIC 50 cups — AB FDA listed —
Atovaquone 750 mg/5mL 42239-0001-08 Abon 1 bottle — AB FDA listed —
Atovaquone 750 mg/5mL 50268-0119-12 AvPAK 20 cups — AB FDA listed —
Atovaquone 750 mg/5mL 51407-0642-87 Golden 1 bottle — AB FDA listed —
Atovaquone 750 mg/5mL 68999-0528-24 Chartwell 10 cups — AB FDA listed —
Atovaquone 750 mg/5mL 73141-0104-42 A2A 42 cups — AB FDA listed —
Atovaquone 750 mg/5mL 73190-0098-21 AvKARE 1 bottle — AB FDA listed —
Atovaquone 750 mg/5mL 81033-0104-22 Kesin 20 cups — AB FDA listed —
Atovaquone Oral Suspension 750 mg/5mL 81033-0105-22 Kesin 20 cups — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1998
On the market since
Sep 1998
📍
2026
Currently FDA-listed
28 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGlaxoSmithKline LLC
Application holderGLAXOSMITHKLINE LLC
FDA applicationNDA020500 (NDA)
Labeler code00173
First marketedSep 1998
Product typeHuman Prescription Drug
Portfolio97 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE 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). ( 1.1 ) • Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. ( 1.2 ) Limitations of Use ( 1.3 ) : • Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with MEPRON has not been studied. • The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied.

1.1Prevention of Pneumocystis jirovecii Pneumonia MEPRON oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).

1.2Treatment of Mild-to-Moderate Pneumocystis jirovecii Pneumonia MEPRON oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.

1.3Limitations of Use Clinical experience with MEPRON for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO 2 ] ≤45 mm Hg). Treatment of more severe episodes of PCP with MEPRON has not been studied. The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Prevention of PCP: 1,500 mg (10 mL) once daily with food ( 2.1 ) • Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days ( 2.2 ) • Supplied in foil pouches and bottles: o Foil Pouch: For a 5-mL dose, take entire contents by mouth either by dispensing into a spoon or cup or directly into the mouth. For a 10-mL dose, take entire contents of 2 pouches. ( 2.3 ) o Bottle: Shake bottle gently before use. ( 2.3 )

2.1Dosage for the Prevention of P. jirovecii Pneumonia The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food.

2.2Dosage for the Treatment of Mild-to-Moderate P. jirovecii Pneumonia The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days.

2.3Important Administration Instructions Administer MEPRON oral suspension with food to avoid low plasma atovaquone concentrations that may limit response to therapy [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. MEPRON Foil Pouch • Open each 5-mL pouch by folding along the dotted line and tearing open at horizontal slit as directed by arrow on pouch. • For a 5-mL dose, take entire contents either by placing directly into the mouth or by dispensing into a dosing spoon (5 mL) or cup prior to administration by mouth. • For a 10-mL dose, take the entire contents of 2 pouches.

MEPRON Bottle Shake bottle gently before administering the recommended dosage.

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS MEPRON is a bright yellow, citrus-flavored, oral suspension containing 750 mg of atovaquone per 5 mL. MEPRON is supplied in 210-mL bottles or 5-mL foil pouches. Oral suspension: 750 mg per 5 mL ( 3 )

⛔ Contraindications 56 words ▾

4 CONTRAINDICATIONS MEPRON oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions to atovaquone or any of the components of MEPRON [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 )] . Known serious allergic/hypersensitivity reaction to atovaquone or any of the components of MEPRON. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Failure to administer MEPRON oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Patients with gastrointestinal disorders may have limited absorption resulting in suboptimal atovaquone concentrations. ( 5.1 ) • Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported.

( 5.2 ) • Severe Cutaneous Adverse Reactions (SCARs): Cases of SCARs such as Stevens-Johnson Syndrome (SJS) have been reported. SCARs can be life-threatening or fatal. If symptoms or signs of SCARs develop, discontinue MEPRON immediately and institute appropriate therapy.

( 5.3 )

5.1Risk of Limited Oral Absorption Absorption of orally administered MEPRON oral suspension is limited but can be significantly increased when the drug is taken with food. Failure to administer MEPRON oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Consider therapy with other agents in patients who have difficulty taking MEPRON oral suspension with food or in patients who have gastrointestinal disorders that may limit absorption of oral medications [see Clinical Pharmacology ( 12.3 )].

5.2Hepatotoxicity Cases of cholestatic hepatitis, elevated liver enzymes, and fatal liver failure have been reported in patients treated with atovaquone [see Adverse Reactions ( 6.2 )]. If treating patients with severe hepatic impairment, closely monitor patients following administration of MEPRON.

5.3Severe Cutaneous Adverse Reactions Cases of severe cutaneous adverse reactions (SCARs), including Stevens‑Johnson Syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme (EM) have been reported in patients treated with MEPRON [see Adverse Reactions ( 6.2 )]. SCARs can be life‑threatening or fatal. If symptoms or signs of SCARs develop, discontinue MEPRON immediately and institute appropriate therapy.

Patients who have developed SCARs with the use of MEPRON must not receive MEPRON [see Contraindications ( 4 )].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in another section of the labeling: • Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] . • PCP Prevention: The most frequent adverse reactions (≥25% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. ( 6.1 ) • PCP Treatment: The most frequent adverse reactions (≥14% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Additionally, because many subjects who participated in clinical trials with MEPRON had complications of advanced human immunodeficiency virus (HIV) disease, it was often difficult to distinguish adverse reactions caused by MEPRON from those caused by underlying medical conditions.

PCP Prevention Trials In 2 clinical trials, MEPRON oral suspension was compared with dapsone or aerosolized pentamidine in HIV-1–infected adolescent (13 to 18 years) and adult subjects at risk of PCP (CD4 count <200 cells/mm 3 or a prior episode of PCP) and unable to tolerate TMP-SMX. Dapsone Comparative Trial: In the dapsone comparative trial (n = 1,057), the majority of subjects were white (64%), male (88%), and receiving prophylaxis for PCP at randomization (73%); the mean age was 38 years. Subjects received MEPRON oral suspension 1,500 mg once daily (n = 536) or dapsone 100 mg once daily (n = 521); median durations of exposure were 6.7 and 6.5 months, respectively.

Adverse reaction data were collected only for adverse reactions requiring discontinuation of treatment, which occurred at similar frequencies in subjects treated with MEPRON oral suspension or dapsone ( Table 1 ). Among subjects taking neither dapsone nor atovaquone at enrollment (n = 487), adverse reactions requiring discontinuation of treatment occurred in 43% of subjects treated with dapsone and 20% of subjects treated with MEPRON oral suspension. Gastrointestinal adverse reactions (nausea, diarrhea, and vomiting) were more frequently reported in subjects treated with MEPRON oral suspension ( Table 1 ).

Table 1. Percentage (>2%) of Subjects with Selected Adverse Reactions Requiring Discontinuation of Treatment in the Dapsone Comparative PCP Prevention Trial Adverse Reaction All Subjects MEPRON Oral Suspension 1,500 mg/day (n = 536) % Dapsone 100 mg/day (n = 521) % Rash 6.3

8.8Nausea 4.1

0.6Diarrhea 3.2

0.2Vomiting 2.2

0.6Aerosolized Pentamidine Comparative Trial: In the aerosolized pentamidine comparative trial (n = 549), the majority of subjects were white (79%), male (92%), and were primary prophylaxis patients at enrollment (58%); the mean age was 38 years. Subjects received MEPRON oral suspension once daily at a dose of 750 mg (n = 188) or 1,500 mg (n = 175) or received aerosolized pentamidine 300 mg every 4 weeks (n = 186); the median durations of exposure were 6.2, 6.0, and 7.8 months, respectively. Table 2 summarizes the clinical adverse reactions reported by ≥20% of the subjects receiving either the 1,500-mg dose of MEPRON oral suspension or aerosolized pentamidine.

Rash occurred more often in subjects treated with MEPRON oral suspension (46%) than in subjects treated with aerosolized pentamidine (28%). Treatment‑limiting adverse reactions occurred in 25% of subjects treated with MEPRON oral suspension 1,500 mg once daily and in 7% of subjects treated with aerosolized pentamidine. The most frequent adverse reactions requiring discontinuation of dosing in the group receiving MEPRON oral susp… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with MEPRON oral suspension is not recommended. ( 7.1 ) • Concomitant administration of tetracycline reduces atovaquone concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of MEPRON if coadministration of tetracycline is necessary.

( 7.2 ) • Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. ( 7.3 ) • Concomitant administration of indinavir reduces indinavir trough concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of indinavir if coadministration is necessary.

( 7.4 )

7.1Rifampin/Rifabutin Concomitant administration of rifampin or rifabutin and MEPRON oral suspension is known to reduce atovaquone concentrations [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of MEPRON oral suspension and rifampin or rifabutin is not recommended.

7.2Tetracycline Concomitant administration of tetracycline and MEPRON oral suspension has been associated with a reduction in plasma concentrations of atovaquone [see Clinical Pharmacology ( 12.3 )]. Caution should be used when prescribing tetracycline concomitantly with MEPRON oral suspension. Monitor patients for potential loss of efficacy of MEPRON if coadministration is necessary.

7.3Metoclopramide Metoclopramide may reduce the bioavailability of atovaquone and should be used only if other antiemetics are not available [see Clinical Pharmacology ( 12.3 )].

7.4Indinavir Concomitant administration of atovaquone and indinavir did not result in any change in the steady-state AUC and C max of indinavir but resulted in a decrease in the C trough of indinavir [see Clinical Pharmacology ( 12.3 )]. Caution should be exercised when prescribing MEPRON oral suspension with indinavir due to the decrease in trough concentrations of indinavir. Monitor patients for potential loss of efficacy of indinavir if coadministration with MEPRON oral suspension is necessary.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from postmarketing experience with use of MEPRON in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women with HIV who are infected with PCP are at increased risk of adverse pregnancy outcomes (see Clinical Considerations) . Atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Pregnant women with HIV who are infected with PCP are at increased risk of severe illness and maternal death associated with PCP compared with non-pregnant women. Data Animal Data: Atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day to pregnant rats during organogenesis (Gestation Day [GD] 6 to GD15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of PCP based on steady-state plasma concentrations.

In pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day during organogenesis (GD6 to GD18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. In a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from GD15 until Lactation Day (LD) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of PCP.

Atovaquone crossed the placenta and was present in fetal rat and rabbit tissue.

8.2Lactation Risk Summary There are no data on the presence of atovaquone in human milk, the effects on the breastfed child, or the effects on milk production. Atovaquone was detected in rat milk when lactating rats were administered oral atovaquone (see Data) . When a drug is present in animal milk, it is likely the drug will be present in human milk.

For women with HIV‑1, potential risks of breastfeeding include HIV‑1 transmission (in infants without HIV‑1). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MEPRON and any potential adverse effects on the breastfed child from MEPRON or from the underlying maternal condition. Data In a rat study with doses of 10 and 250 mg/kg given orally by gavage on postpartum Day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses.

The concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk.

8.4Pediatric Use Evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. In a trial of MEPRON oral suspension administered once daily with food for 12 days to 27 HIV-1–infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. The average steady-state plasma atovaquone concentrations in the 24 subj… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from postmarketing experience with use of MEPRON in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women with HIV who are infected with PCP are at increased risk of adverse pregnancy outcomes (see Clinical Considerations) . Atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Pregnant women with HIV who are infected with PCP are at increased risk of severe illness and maternal death associated with PCP compared with non-pregnant women. Data Animal Data: Atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day to pregnant rats during organogenesis (Gestation Day [GD] 6 to GD15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of PCP based on steady-state plasma concentrations.

In pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day during organogenesis (GD6 to GD18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. In a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from GD15 until Lactation Day (LD) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of PCP.

Atovaquone crossed the placenta and was present in fetal rat and rabbit tissue.

🧒 Pediatric Use 160 words ▾

8.4Pediatric Use Evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. In a trial of MEPRON oral suspension administered once daily with food for 12 days to 27 HIV-1–infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. The average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in Table 5 .

Table 5. Average Steady-State Plasma Atovaquone Concentrations in Pediatric Subjects C ss = Concentration at steady state. Age Dose of MEPRON Oral Suspension 10 mg/kg 30 mg/kg 45 mg/kg Average C ss in mcg/mL (mean ± SD) 1-3 months 5.9 (n = 1) 27.8 ± 5.8 (n = 4) _ >3-24 months 5.7 ± 5.1 (n = 4) 9.8 ± 3.2 (n = 4) 15.4 ± 6.6 (n = 4) >2-13 years 16.8 ± 6.4 (n = 4) 37.1 ± 10.9 (n = 3) _

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Clinical trials of MEPRON did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

🆘 Overdosage 49 words ▾

10 OVERDOSAGE Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose. There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atovaquone is a quinone antimicrobial drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics Relationship between Plasma Atovaquone Concentrations and Clinical Outcome In a comparative clinical trial, HIV/AIDS subjects received atovaquone tablets 750 mg 3 times daily or TMP‑SMX for treatment of mild‑to‑moderate PCP for 21 days [see Clinical Studies ( 14.2 )] ; the relationship between atovaquone plasma concentrations and successful treatment outcome from 113 of these subjects for whom both steady-state drug concentrations and outcome data were available is shown in Table 6 . Table 6. Relationship between Plasma Atovaquone Concentrations and Successful Treatment Outcome a Successful treatment outcome was defined as improvement in clinical and respiratory measures persisting at least 4 weeks after cessation of therapy.

Improvement in clinical and respiratory measures was assessed using a composite of parameters that included oral body temperature, respiratory rate, and severity scores for cough, dyspnea, and chest pain/tightness. Steady ‑ State Plasma Atovaquone Concentrations (mcg/mL) Successful Treatment a No. of Successes/No. in Group (%) 0 to <5 0/6 (0%) 5 to <10 18/26 (69%) 10 to <15 30/38 (79%) 15 to <20 18/19 (95%) ≥20 24/24 (100%) Cardiac Effects The effect of MEPRON oral suspension on the QT interval is unknown in humans.

12.3Pharmacokinetics Plasma atovaquone concentrations do not increase proportionally with dose following ascending repeat-dose administration of MEPRON oral suspension in healthy subjects. When MEPRON oral suspension was administered with food at dosage regimens of 500 mg once daily, 750 mg once daily, and 1,000 mg once daily, mean (±SD) steady-state plasma atovaquone concentrations were 11.7 ± 4.8, 12.5 ± 5.8, and 13.5 ± 5.1 mcg/mL, respectively. The corresponding mean (±SD) C max concentrations were 15.1 ± 6.1, 15.3 ± 7.6, and 16.8 ± 6.4 mcg/mL.

Absorption Atovaquone is a highly lipophilic compound with low aqueous solubility. The mean (±SD) absolute bioavailability of atovaquone from a 750‑mg dose of MEPRON oral suspension administered under fed conditions in 9 HIV-1–infected (CD4 >100 cells/mm 3 ) volunteers was 47% ± 15%. Effect of Food: Administering MEPRON oral suspension with food enhances atovaquone bioavailability.

Sixteen healthy subjects received a single 750-mg dose of MEPRON oral suspension after an overnight fast and following a meal (23 g fat: 610 kCal). The mean (±SD) atovaquone AUC under fasting and fed conditions were 324 ± 115 and 801 ± 320 h●mcg/mL, respectively, representing a 2.6 ± 1.0-fold increase. Distribution Following IV administration of atovaquone, the mean (±SD) volume of distribution at steady state (Vd ss ) was 0.60 ±

0.17L/kg (n = 9). Atovaquone is extensively bound to plasma proteins (99.9%) over the concentration range of 1 to 90 mcg/mL. In 3 HIV-1–infected children who received 750 mg atovaquone as the tablet formulation 4 times daily for 2 weeks, the cerebrospinal fluid concentrations of atovaquone were 0.04, 0.14, and 0.26 mcg/mL, representing less than 1% of the plasma concentration.

Elimination The mean (±SD) half-life of atovaquone was 62.5 ± 35.3 hours after IV administration and ranged from 67.0 ± 33.4 to 77.6 ± 23.1 hours following administration of MEPRON oral suspension. Metabolism: The metabolism of atovaquone is unknown. Excretion: Following oral administration of 14 C-labelled atovaquone to healthy subjects, greater than 94% of the dose was recovered as unchanged atovaquone in the feces over 21 days.

Specific Populations Patients with Hepatic or Renal Impairment: The pharmacokinetics of atovaquone have not been studied in patients with hepatic or renal impairment. HIV-Infected Subjects: When MEPRON oral suspension was administered to 5 HIV-1–infected subjects at a dose of 750 mg twice daily, the mean (±SD) steady-state plasma atovaquone concentration was 21.0 ± 4.9 mcg/mL and mean (±SD) C max was 24.… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Atovaquone is a quinone antimicrobial drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 73 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING MEPRON oral suspension (bright yellow, citrus-flavored) containing 750 mg atovaquone per 5 mL. • Bottle of 210 mL with child-resistant cap (NDC 0173-0665-18). Store at 15°C to 25°C (59°F to 77°F). Do not freeze . Dispense in tight container as defined in USP. • 5-mL child‑resistant foil pouch ‑ unit dose pack of 42 (NDC 0173-0547-00). Store at 15°C to 25°C (59°F to 77°F). Do not freeze .

📋 Description 99 words ▾

11 DESCRIPTION MEPRON (atovaquone oral suspension) is a quinone antimicrobial drug. The chemical name of atovaquone is trans -2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water.

It has a molecular weight of 366.84 and the molecular formula C 22 H 19 ClO 3 . The compound has the following structural formula: MEPRON oral suspension is a formulation of micro‑fine particles of atovaquone. Each 5 mL of MEPRON oral suspension contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum. atovaquone molecular chemical structure

💬 Information for Patients 178 words ▾

17 PATIENT COUNSELING INFORMATION Important Administration Instructions • Advise patients to take the prescribed dose of MEPRON oral suspension as directed. • Advise patients to take their daily doses of MEPRON oral suspension with food, as food will significantly improve the absorption of the drug [see Dosage and Administration ( 2.3 )] . • Advise patients to shake MEPRON oral suspension gently before use each time [see Dosage and Administration ( 2.3 )] . Severe Cutaneous Adverse Reactions (SCARs) Advise patients about the signs and symptoms of serious skin manifestations.

Instruct patients to stop taking MEPRON immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions ( 5.3 )] . Lactation Inform women with HIV‑1 that the potential risks of breastfeeding include HIV‑1 transmission (in infants without HIV‑1) [see Use in Specific Populations ( 8.2 )] . Trademarks are owned by or licensed to the GSK group of companies.

Distributed by: GlaxoSmithKline Durham, NC 27701 ©2026 GSK group of companies or its licensor. MPR:12PI

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Plasma atovaquone concentrations do not increase proportionally with dose following ascending repeat-dose administration of MEPRON oral suspension in healthy subjects. When MEPRON oral suspension was administered with food at dosage regimens of 500 mg once daily, 750 mg once daily, and 1,000 mg once daily, mean (±SD) steady-state plasma atovaquone concentrations were 11.7 ± 4.8, 12.5 ± 5.8, and 13.5 ± 5.1 mcg/mL, respectively. The corresponding mean (±SD) C max concentrations were 15.1 ± 6.1, 15.3 ± 7.6, and 16.8 ± 6.4 mcg/mL.

Absorption Atovaquone is a highly lipophilic compound with low aqueous solubility. The mean (±SD) absolute bioavailability of atovaquone from a 750‑mg dose of MEPRON oral suspension administered under fed conditions in 9 HIV-1–infected (CD4 >100 cells/mm 3 ) volunteers was 47% ± 15%. Effect of Food: Administering MEPRON oral suspension with food enhances atovaquone bioavailability.

Sixteen healthy subjects received a single 750-mg dose of MEPRON oral suspension after an overnight fast and following a meal (23 g fat: 610 kCal). The mean (±SD) atovaquone AUC under fasting and fed conditions were 324 ± 115 and 801 ± 320 h●mcg/mL, respectively, representing a 2.6 ± 1.0-fold increase. Distribution Following IV administration of atovaquone, the mean (±SD) volume of distribution at steady state (Vd ss ) was 0.60 ±

0.17L/kg (n = 9). Atovaquone is extensively bound to plasma proteins (99.9%) over the concentration range of 1 to 90 mcg/mL. In 3 HIV-1–infected children who received 750 mg atovaquone as the tablet formulation 4 times daily for 2 weeks, the cerebrospinal fluid concentrations of atovaquone were 0.04, 0.14, and 0.26 mcg/mL, representing less than 1% of the plasma concentration.

Elimination The mean (±SD) half-life of atovaquone was 62.5 ± 35.3 hours after IV administration and ranged from 67.0 ± 33.4 to 77.6 ± 23.1 hours following administration of MEPRON oral suspension. Metabolism: The metabolism of atovaquone is unknown. Excretion: Following oral administration of 14 C-labelled atovaquone to healthy subjects, greater than 94% of the dose was recovered as unchanged atovaquone in the feces over 21 days.

Specific Populations Patients with Hepatic or Renal Impairment: The pharmacokinetics of atovaquone have not been studied in patients with hepatic or renal impairment. HIV-Infected Subjects: When MEPRON oral suspension was administered to 5 HIV-1–infected subjects at a dose of 750 mg twice daily, the mean (±SD) steady-state plasma atovaquone concentration was 21.0 ± 4.9 mcg/mL and mean (±SD) C max was 24.0 ± 5.7 mcg/mL. The mean (±SD) minimum plasma atovaquone concentration (C min ) associated with the 750‑mg twice-daily regimen was 16.7 ± 4.6 mcg/mL.

In an open-label PCP trial in 18 HIV-1–infected subjects, administration of MEPRON oral suspension 750 mg twice daily with meals resulted in a mean (±SD) steady‑state plasma atovaquone concentration of 22.0 ± 10.1 mcg/mL. The mean (±SD) plasma clearance of atovaquone following IV administration in 9 HIV-1–infected subjects was 10.4 ± 5.5 mL/min (0.15 ± 0.09 mL/min/kg). Drug Interaction Studies Rifampin/Rifabutin: In a trial with 13 HIV-1–infected volunteers, the oral administration of rifampin 600 mg every 24 hours with MEPRON oral suspension 750 mg every 12 hours resulted in a 52% ± 13% decrease in the mean (±SD) steady‑state plasma atovaquone concentration and a 37% ± 42% increase in the mean (±SD) steady‑state plasma rifampin concentration.

The half‑life of atovaquone decreased from 82 ± 36 hours when administered without rifampin to 50 ± 16 hours with rifampin. In a trial of 24 healthy volunteers, the oral administration of rifabutin 300 mg once daily with MEPRON oral suspension 750 mg twice daily resulted in a 34% decrease in the mean steady‑state plasma atovaquone concentration and a 19% decrease in the mean steady‑state plasma rifabutin concentration. Tetracycline: Concomitant treatment with tetracycline has been associated wi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 191 words ▾

12.2Pharmacodynamics Relationship between Plasma Atovaquone Concentrations and Clinical Outcome In a comparative clinical trial, HIV/AIDS subjects received atovaquone tablets 750 mg 3 times daily or TMP‑SMX for treatment of mild‑to‑moderate PCP for 21 days [see Clinical Studies ( 14.2 )] ; the relationship between atovaquone plasma concentrations and successful treatment outcome from 113 of these subjects for whom both steady-state drug concentrations and outcome data were available is shown in Table 6 . Table 6. Relationship between Plasma Atovaquone Concentrations and Successful Treatment Outcome a Successful treatment outcome was defined as improvement in clinical and respiratory measures persisting at least 4 weeks after cessation of therapy.

Improvement in clinical and respiratory measures was assessed using a composite of parameters that included oral body temperature, respiratory rate, and severity scores for cough, dyspnea, and chest pain/tightness. Steady ‑ State Plasma Atovaquone Concentrations (mcg/mL) Successful Treatment a No. of Successes/No. in Group (%) 0 to <5 0/6 (0%) 5 to <10 18/26 (69%) 10 to <15 30/38 (79%) 15 to <20 18/19 (95%) ≥20 24/24 (100%) Cardiac Effects The effect of MEPRON oral suspension on the QT interval is unknown in humans.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Prevention of PCP The indication for prevention of PCP is based on the results of 2 clinical trials comparing MEPRON oral suspension with dapsone or aerosolized pentamidine in HIV-1–infected adolescent (aged 13 to 18 years) and adult subjects at risk of PCP (CD4 count <200 cells/mm 3 or a prior episode of PCP) and unable to tolerate TMP‑SMX. Dapsone Comparative Trial This open-label trial enrolled 1,057 subjects, randomized to receive MEPRON oral suspension 1,500 mg once daily (n = 536) or dapsone 100 mg once daily (n = 521).

The majority of subjects were white (64%), male (88%), and receiving prophylaxis for PCP at randomization (73%); the mean age was 38 years. Median follow-up was 24 months. Subjects randomized to the dapsone arm who were seropositive for Toxoplasma gondii and had a CD4 count <100 cells/mm 3 also received pyrimethamine and folinic acid.

PCP event rates are shown in Table 7 . Mortality rates were similar. Aerosolized Pentamidine Comparative Trial This open-label trial enrolled 549 subjects, randomized to receive MEPRON oral suspension 1,500 mg once daily (n = 175), MEPRON oral suspension 750 mg once daily (n = 188), or aerosolized pentamidine 300 mg once monthly (n = 186).

The majority of subjects were white (79%), male (92%), and were primary prophylaxis patients at enrollment (58%); the mean age was 38 years. Median follow-up was 11.3 months. The results of the PCP event rates appear in Table 7 .

Mortality rates were similar among the groups. Table 7. Confirmed or Presumed/Probable PCP Events (As-Treated Analysis) a a Those events occurring during or within 30 days of stopping assigned treatment. b Relative risk <1 favors MEPRON and values >1 favor comparator.

Trial results did not show superiority of MEPRON to the comparator. c The confidence level of the interval for the dapsone comparative trial was 95% and for the pentamidine comparative trial was 97.5%. Assessment Trial 1 Trial 2 MEPRON Oral Suspension 1,500 mg/day (n = 527) Dapsone 100 mg/day (n = 510) MEPRON Oral Suspension 750 mg/day (n = 188) MEPRON Oral Suspension 1,500 mg/day (n = 172) Aerosolized Pentamidine 300 mg/month (n = 169) % 15 19 23 18 17 Relative Risk b (CI) c 0.77 (0.57, 1.04) 1.47 (0.86, 2.50) 1.14 (0.63, 2.06) An analysis of all PCP events (intent-to-treat analysis) for both trials showed results similar to those shown in Table 7 .

14.2Treatment of PCP The indication for treatment of mild‑to‑moderate PCP is based on the results of 2 efficacy trials: a randomized, double‑blind trial comparing MEPRON tablets with TMP‑SMX in subjects with HIV/AIDS and mild‑to‑moderate PCP (defined in the protocol as [(A‑a)DO 2 ] ≤45 mm Hg and PaO 2 ≥60 mm Hg on room air) and a randomized open-label trial comparing MEPRON tablets with IV pentamidine isethionate in subjects with mild‑to‑moderate PCP who could not tolerate trimethoprim or sulfa antimicrobials. Both trials were conducted with the tablet formulation using 750 mg 3 times daily.

Results from these efficacy trials established a relationship between plasma atovaquone concentrations and successful outcome. Successful outcome was defined as improvement in clinical and respiratory measures persisting at least 4 weeks after cessation of therapy [see Clinical Pharmacology ( 12.2 )] . TMP‑SMX Comparative Trial This double‑blind, randomized trial compared the safety and efficacy of MEPRON tablets with that of TMP‑SMX for the treatment of subjects with HIV/AIDS and histologically confirmed PCP.

Only subjects with mild‑to‑moderate PCP were eligible for enrollment. A total of 408 subjects were enrolled into the trial. The majority of subjects were white (66%) and male (95%); the mean age was 36 years.

Eighty‑six subjects without histologic confirmation of PCP were excluded from the efficacy analyses. Of the 322 subjects with histologically confirmed PCP, 160 were randomized to receive 750 mg MEPRON (three 250-mg tablets) 3 times daily for 21 days and 162 were randomized to rece… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 177 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies in rats were negative; 24‑month studies in mice (dosed with 50, 100, or 200 mg/kg/day) showed treatment‑related increases in incidence of hepatocellular adenoma and hepatocellular carcinoma at all doses tested, which correlated with 1.4 to 3.6 times the average steady-state plasma concentrations in humans during acute treatment of PCP. Atovaquone was negative with or without metabolic activation in the Ames Salmonella mutagenicity assay, the mouse lymphoma mutagenesis assay, and the cultured human lymphocyte cytogenetic assay.

No evidence of genotoxicity was observed in the in vivo mouse micronucleus assay. Impairment of Fertility Atovaquone administered by oral gavage in doses of 100, 300, or 1,000 mg/kg/day to adult male rats from 73 days prior to mating until 20 days after mating and to adult female rats from 14 days prior to mating until LD20 did not impair male or female fertility or early embryonic development at doses up to 1,000 mg/kg/day corresponding to plasma exposures of approximately 3 times the estimated human exposure based on steady-state plasma concentrations.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 174 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies in rats were negative; 24‑month studies in mice (dosed with 50, 100, or 200 mg/kg/day) showed treatment‑related increases in incidence of hepatocellular adenoma and hepatocellular carcinoma at all doses tested, which correlated with 1.4 to 3.6 times the average steady-state plasma concentrations in humans during acute treatment of PCP. Atovaquone was negative with or without metabolic activation in the Ames Salmonella mutagenicity assay, the mouse lymphoma mutagenesis assay, and the cultured human lymphocyte cytogenetic assay.

No evidence of genotoxicity was observed in the in vivo mouse micronucleus assay. Impairment of Fertility Atovaquone administered by oral gavage in doses of 100, 300, or 1,000 mg/kg/day to adult male rats from 73 days prior to mating until 20 days after mating and to adult female rats from 14 days prior to mating until LD20 did not impair male or female fertility or early embryonic development at doses up to 1,000 mg/kg/day corresponding to plasma exposures of approximately 3 times the estimated human exposure based on steady-state plasma concentrations.

📄 Recent Major Changes 11 words ▾

Warnings and Precautions, Severe Cutaneous Adverse Reactions ( 5.3 ) 3/2026

📄 Package Label / Principal Display Panel 170 words ▾

PRINCIPAL DISPLAY PANEL NDC 0173-0665-18 MEPRON (atovaquone oral suspension) 750 mg/5 mL Each 5 mL (1 teaspoonful) contains 750 mg atovaquone. R x only GSK 210 mL See accompanying prescribing information for Dosage and Administration. Store at 15 o to 25 o C (59 o to 77 o F).

DO NOT FREEZE. Dispense in a tight container as defined in USP. SHAKE GENTLY BEFORE USING.

Distributed by: GlaxoSmithKline Durham, NC 27701 Made in India A001306 (30000000001306) Rev. 2/24 Mepron 750 mg label

PRINCIPAL DISPLAY PANEL NDC 0173-0547-00 MEPRON (atovaquone oral suspension) 750 mg/ 5mL Each 5 mL sachet (1 teaspoonful) contains 750 mg atovaquone. Store at 15 o to 25 o C (59 o to 77 o F). DO NOT FREEZE.

Do not accept if security seal is missing or broken. See accompanying prescribing information for Dosage and Administration. 5 mL R x only Contains 42 sachets of 5 mL each GSK ©2024 GSK group of companies or its licensor.

A001308 (30000000001308) Rev. 2/24 Mepron 750 mg 42 count carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mepron — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mepron. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$37.4K
Claims incl. refills
23
Beneficiaries
14
Spend / beneficiary
$2,668.26
Spend / claim
$1,624.16
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for MEPRON (this brand).

Top reported reactions

Pyrexia442
Diarrhoea423
Nausea396
Pneumonia385
Death318
Fatigue305
Dyspnoea290

Age at onset

Neonate13
Infant11
Child14
Adolescent16
Adult821
Elderly669

Reporter sex

7,983 reports
Male · 57%
Female · 43%
Unknown · 0%

Serious outcomes

Hospitalization4,053
Death1,348
Life-threatening640
Disabling123
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 992 479
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by GlaxoSmithKline LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GlaxoSmithKline LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00173-0527-00 · GlaxoSmithKline 00173-0565-04 · GlaxoSmithKline →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.