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atovaquone 750 mg/5mL Suspension — NDC 68462-421-69 (Billing 68462-0421-69)

by Glenmark Pharmaceuticals Inc., USA · 42 POUCH in 1 CARTON / 5 mL in 1 POUCH

This is a package of atovaquone 750 mg/5mL Suspension from Glenmark Pharmaceuticals Inc., USA, marketed since Dec 2017 and currently FDA-listed; retail pharmacies pay about $0.7668 per mL (NADAC).

NDC 68462-0421-69
🏷️ FDA NDC (as labeled) 68462-421-69 billing pads the product segment with a zero
This package
Contains5 mL in 1 pouch Cost per mL$0.7668 NADAC Per package$161.03 / 210 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.8965/unit · Part D plans $1.30/unit — full pricing hub ↓
Product page 68462-0421-21 Also comes in: 210 ml 68462-421-21
Rx only Generic 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

NDC database record

One package, one record: these facts belong to NDC 68462-421-69 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68462 labeler · 421 product · 69 package
Package marketed since
Dec 31, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0368462421215
Medicaid fills, this package
33 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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) 68462-421-69
Product NDC 68462-421
11-digit billing NDC 68462042169
NCPDP billing unit ML — per mL (volume)
RxCUI 308429
UNII Y883P1Z2LT
UPC 0368462421215
Application # ANDA209685
SPL Set ID 9045ba6f-938e-4717-bfa2-a3efe52f04cd
Established class (EPC) Antimalarial; Antiprotozoal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-31
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
GPI class Atovaquone
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 ATOVAQUONE 750 MG/5 ML SUSP
FDB brand name Atovaquone
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): 308429
Why two NDCs? The FDA registers this code as 68462-421-69 — a 5-3-2 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 product segment → 68462-0421-69. 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 ATOVAQUONE 750 MG/5 ML SUSP 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 $0.767 $161.03 / 210 ml
Medicaid paysCMS SDUD · 12 mo $0.8965 $188.27 / 210 ml
Medicare drug plans payPart D · Q2 2026 $1.30 $273.53 / 210 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Aug 2022 Jan 2026 Sep 2026 $1.319 $0.684
▼ Down 6% over the last 24 months.
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 Per unit Per pack Marketing startMarketing endStatus
68462-0421-21 68462-421-21 Main listing 210 mL in 1 BOTTLE $0.7668 / mL $161.04 2017-12-31 — Active
68462-0421-69 You're viewing this 42 POUCH in 1 CARTON / 5 mL in 1 POUCH $0.7668 / mL $161.04 2017-12-31 — Active

This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($0.7668 NADAC).

This pack accounts for about 0.8% of this product's recent Medicaid fills; most go to the 210 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 42 pouch in 1 carton / 5 ml in 1 pouch.
What NDC number is used to bill for this package of atovaquone 750 mg/5mL Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atovaquone 750 mg/5mL 70748-0299-01 Lupin 1 bottle $0.719 AB FDA listed save 6%
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/5mLthis 68462-0421-69 Glenmark 42 pouches $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/5mL 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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🧪 Avoiding an ingredient? See Atovaquone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK SPECIALTY SA
FDA applicationANDA209685 (ANDA)
Labeler code68462
First marketedDec 2017
Product typeHuman Prescription Drug
Portfolio343 products on file

More NDCs from Glenmark Pharmaceuticals Inc., USA labeler code 68462

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 Atovaquone 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 atovaquone has not been studied. • The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.

1.1Prevention of Pneumocystis jirovecii Pneumonia Atovaquone 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 Atovaquone 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 atovaquone oral suspension 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 atovaquone oral suspension has not been studied. The efficacy of atovaquone oral suspension 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 two 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 atovaquone 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 )]. Atovaquone Oral Suspension Foil Pouch • Open each 5 mL pouch by removing tab at perforation and tear at notch. • 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 two pouches.

Atovaquone Oral Suspension Bottle Shake bottle gently before administering the recommended dosage.

💊 Dosage Forms and Strengths 52 words ▾

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

⛔ Contraindications 60 words ▾

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

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Failure to administer atovaquone 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 atovaquone immediately and institute appropriate therapy.

( 5.3 )

5.1Risk of Limited Oral Absorption Absorption of orally administered atovaquone oral suspension is limited but can be significantly increased when the drug is taken with food. Failure to administer atovaquone 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 atovaquone 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 atovaquone.

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 atovaquone [see Adverse Reactions ( 6.2 )] . SCARs can be life-threatening or fatal. If symptoms or signs of SCARs develop, discontinue atovaquone immediately and institute appropriate therapy.

Patients who have developed SCARs with the use of atovaquone must not receive atovaquone [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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 atovaquone had complications of advanced human immunodeficiency virus (HIV) disease, it was often difficult to distinguish adverse reactions caused by atovaquone from those caused by underlying medical conditions.

PCP Prevention Trials In two clinical trials, atovaquone 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 atovaquone 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 atovaquone 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 atovaquone oral suspension. Gastrointestinal adverse reactions (nausea, diarrhea, and vomiting) were more frequently reported in subjects treated with atovaquone 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 Atovaquone 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 atovaquone 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, 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 atovaquone oral suspension or aerosolized pentamidine.

Rash occurred more often in subjects treated with atovaquone oral suspension (46%) than in subjects treated with aerosolized pentamidine (28%). Treatment‑limiting adverse reactions occurred in 25% of subjects treated with atovaquone oral suspension 1,500 mg once daily and in 7% of subjects treated with aerosolized pentamidine. The most frequent adverse reactions requiring di… [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 atovaquone 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 atovaquone 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 atovaquone oral suspension is known to reduce atovaquone concentrations [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of atovaquone oral suspension and rifampin or rifabutin is not recommended.

7.2Tetracycline Concomitant administration of tetracycline and atovaquone 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 atovaquone oral suspension. Monitor patients for potential loss of efficacy of atovaquone 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 atovaquone 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 atovaquone 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 atovaquone 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 atovaquone and any potential adverse effects on the breastfed child from atovaquone 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 atovaquone 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 concentration… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from postmarketing experience with use of atovaquone 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 165 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 atovaquone 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 Age Dose of Atovaquone Oral Suspension 10 mg/kg 30 mg/kg 45 mg/kg Average C ss in mcg/mL (mean ± SD) 1 to 3 months 5.9 (n = 1) 27.8 ± 5.8 (n = 4) _ >3 to 24 months 5.7 ± 5.1 (n = 4) 9.8 ± 3.2 (n = 4) 15.4 ± 6.6 (n = 4) >2 to 13 years 16.8 ± 6.4 (n = 4) 37.1 ± 10.9 (n = 3) _ C ss = Concentration at steady state.

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Clinical trials of atovaquone 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 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%) 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. Cardiac Effects The effect of atovaquone 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 atovaquone oral suspension in healthy subjects. When atovaquone 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 atovaquone oral suspension administered under fed conditions in 9 HIV-1-infected (CD4 >100 cells/mm 3 ) volunteers was 47% ± 15%. Effect of Food: Administering atovaquone oral suspension with food enhances atovaquone bioavailability.

Sixteen healthy subjects received a single 750 mg- dose of atovaquone 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-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 ± 33.4 to 77.6 ± 23.1 hours following administration of atovaquone oral suspension. Metabolism: The metabolism of atovaquone is unknown. Excretion: Following oral administration of 14 C-labelled atovaquone was administered 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 atovaquone 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 ±… [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 85 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP per 5 mL. It is supplied as follows: NDC 68462-421-21 Bottle of 210 mL with child-resistant cap NDC 68462-421-69 Carton of 42 sachets (5 mL unit-dose NDC 68462-421-05) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Dispense in tight container as defined in USP.

📋 Description 145 words ▾

11 DESCRIPTION Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is trans -2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; 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: Atovaquone Oral Suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of Atovaquone Oral Suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum. structure

💬 Information for Patients 170 words ▾

17 PATIENT COUNSELING INFORMATION Important Administration Instructions • Advise patients to take the prescribed dose of atovaquone oral suspension as directed. • Advise patients to take their daily doses of atovaquone oral suspension with food, as food will significantly improve the absorption of the drug [see Dosage and Administration ( 2.3 )]. • Advise patients to shake atovaquone 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 atovaquone oral suspension 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 )] . Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions?

1 (888) 721-7115 www.glenmarkpharma-us.com May 2026 logo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Plasma atovaquone concentrations do not increase proportionally with dose following ascending repeat-dose administration of atovaquone oral suspension in healthy subjects. When atovaquone 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 atovaquone oral suspension administered under fed conditions in 9 HIV-1-infected (CD4 >100 cells/mm 3 ) volunteers was 47% ± 15%. Effect of Food: Administering atovaquone oral suspension with food enhances atovaquone bioavailability.

Sixteen healthy subjects received a single 750 mg- dose of atovaquone 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-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 ± 33.4 to 77.6 ± 23.1 hours following administration of atovaquone oral suspension. Metabolism: The metabolism of atovaquone is unknown. Excretion: Following oral administration of 14 C-labelled atovaquone was administered 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 atovaquone 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 ± 4.9 mcg/mL and mean (±SD) C max was 24 ± 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 atovaquone oral suspension 750 mg twice daily with meals resulted in a mean (±SD) steady-state plasma atovaquone concentration of 22 ± 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 atovaquone 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 atovaquone 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 tr… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 187 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 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%) 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. Cardiac Effects The effect of atovaquone 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 atovaquone 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 atovaquone 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 atovaquone oral suspension 1,500 mg once daily (n = 175), atovaquone 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 Assessment Trial 1 Trial 2 Atovaquone Oral Suspension 1,500 mg/day (n = 527) Dapsone 100 mg/day (n = 510) Atovaquone Oral Suspension 750 mg/day (n = 188) Atovaquone Oral Suspension 1,500 mg/day (n = 172) Aerosolized Pentamidine 300 mg/month (n = 169) % 15 19 23 18 17 Relative Risk b 0.77 1.47 1.14 (CI) c (0.57, 1.04) (0.86, 2.50) (0.63, 2.06) a Those events occurring during or within 30 days of stopping assigned treatment. b Relative risk <1 favors atovaquone and values >1 favor comparator.

Trial results did not show superiority of atovaquone 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%. 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 two efficacy trials: a randomized, double‑blind trial comparing atovaquone 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 atovaquone 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 three 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 atovaquone 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 atovaquone (three 250 mg tablets)… [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 16 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 68462-421-21 Atovaquone Oral Suspension, USP 750 mg/5 ml Bottle Label label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
33
Units reimbursed last 4 qtrs
7.6K
Gross reimbursed last 4 qtrs
$6.8K
Avg / prescription
$205.38
Avg / unit
$0.8965
Latest quarter Q1 2026
0Rx
Medicaid pays / mL
$0.8965
gross reimbursed
vs
NADAC / mL
$0.7668
acquisition cost
=
Spread
+$0.1297
+17% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 33 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 7,560 units · 38.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
38.638.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 38.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
210 ml68462-0421-21 3,951 Rx · $919,603
42 pouches this page68462-0421-69 33 Rx · $6,778
Drug total (last 4 qtrs): 3,984 Rx · 1,040,416 units · $926,380 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Atovaquone — the program that covers self-administered drugs. 8 manufacturers.
⚠️ 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 Atovaquone. 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
$11.35M
Claims incl. refills
26.7K
Beneficiaries
14.3K
Spend / beneficiary
$792.18
Spend / claim
$425.63
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.
← 68462-0419-29 · Glenmark 68462-0423-15 · Glenmark →
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.