Medicine
Atovaquone 750 mg/5 mL oral suspension
Atovaquone 750 mg/5 mL oral suspension is a generic prescription medicine for oral use, made by 19 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at 15° to 25°C (59° to 77°F).
Key facts
- Active ingredient (INN)
- Atovaquone
- Brand
- Sold under the generic name
- Strength
- 750 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle, 210 mL, 42 pouches and 27 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaCamber PharmaceuticalsIndiaLupinIndiaKesin PharmaPAI PharmaAbon PharmaceuticalsAmerican Health PackagingAtlantic BiologicalsChartwell RXMajor Pharmaceuticals19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 15° to 25°C (59° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01AX06 Atovaquone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 February 2011
- Identifiers
- RxCUI 308429DailyMed set ID f99a8a0c-2b42-4da0-8f5a-e963fc619e8b, 4a2e2c4b-85aa-9b30-e063-6294a90a7bd9, df6086d3-6100-422a-bf23-e9610027749b +18NDC 17856-0631, 81033-105, 0121-0956 +19Application ANDA210692, ANDA210510, ANDA214272 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 210 mL in 1 bottle | 31722-629-21 | Camber PharmaceuticalsIndia | 11 October 2018 |
| 210 mL in 1 bottle | 68462-421-21 | Glenmark PharmaceuticalsIndia | 31 December 2017 |
| 42 pouch in 1 carton / 5 mL in 1 pouch | 68462-421-69 | Glenmark PharmaceuticalsIndia | 31 December 2017 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 70748-299-01 | LupinIndia | 1 June 2021 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 0121-0956-08 | PAI Pharma | 4 April 2025 |
| 3 tray in 1 case / 6 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-1016-18 | PAI Pharma | 10 January 2024 |
| 7 tray in 1 case / 6 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-1016-42 | PAI Pharma | 10 January 2024 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 42239-001-08 | Abon Pharmaceuticals | 14 November 2023 |
| 6 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 42239-001-66 | Abon Pharmaceuticals | 1 May 2025 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 65162-693-88 | Amneal Pharmaceuticals | 9 February 2011 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 69452-252-87 | Bionpharma | 1 June 2021 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-528-24 | Chartwell Governmental & Specialty RX | 25 October 2025 |
| 210 mL in 1 bottle | 62135-528-09 | Chartwell RX | 18 July 2023 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-528-24 | Chartwell RX | 23 May 2024 |
| 1 bottle, plastic in 1 carton / 210 mL in 1 bottle, plastic | 10702-223-21 | KVK-Tech | 29 March 2019 |
| 72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-0631-1 | Atlantic Biologicals | 4 September 2024 |
| 50 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-8631-1 | Atlantic Biologicals | 1 October 2025 |
| 20 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-104-22 | Kesin Pharma | 15 September 2025 |
| 42 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-104-42 | Kesin Pharma | 17 June 2024 |
| 50 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-104-50 | Kesin Pharma | 17 June 2024 |
| 20 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-105-22 | Kesin Pharma | 6 February 2026 |
| 42 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-105-42 | Kesin Pharma | 6 February 2026 |
| 2 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-534-36 | American Health Packaging | 13 July 2023 |
| 7 tray in 1 case / 6 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-534-78 | American Health Packaging | 21 October 2020 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 73190-098-21 | AvKARE | 14 June 2026 |
| 20 cup in 1 box / 5 mL in 1 cup | 50268-119-12 | AvPAK | 14 October 2025 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 51407-642-87 | Golden State Medical Supply | 14 March 2022 |
| 3 tray in 1 case / 6 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-7459-25 | Major Pharmaceuticals | 8 July 2024 |
| 7 tray in 1 case / 6 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-7459-53 | Major Pharmaceuticals | 8 July 2024 |
| 1 bottle in 1 carton / 210 mL in 1 bottle | 72603-248-01 | NorthStar RxLLC | 1 May 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 November 1992 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Atovaquone 750 mg/5 mL oral suspension.
Clinical summary
Atovaquone is an antimalarial indicated for prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX), among other approved uses. It is available as oral suspension. MedsAcross supplies Atovaquone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about AtovaquoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MEPRON prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
Need Atovaquone 750 mg/5 mL oral suspension for your hospital or patient?
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