Medicine
Malarone 250 mg/100 mg tablet
Malarone 250 mg/100 mg tablet is a prescription medicine containing Atovaquone and Proguanil for oral use, marketed by GlaxoSmithKline, 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
Store at 25°C (77°F). Temperature excursions are permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Atovaquone and Proguanil
- Brand
- Malarone
- Strength
- 250 mg/100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 24 tablets
- Marketing authorisation holder
- GlaxoSmithKline
- Manufacturer
- GlaxoSmithKline
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F). Temperature excursions are permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 July 2000
- Identifiers
- RxCUI 864675, 864679, 864681 +1DailyMed set ID fc22e8d8-3bfb-4f70-a599-dd81262a4887NDC 0173-0675Application NDA021078
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 0173-0675-01 | GlaxoSmithKline | 26 July 2000 |
| 24 tablet, film coated in 1 dose pack | 0173-0675-02 | GlaxoSmithKline | 26 July 2000 |
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 14 July 2000 | 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 and Proguanil 250 mg/100 mg tablet.
Other strengths and forms of Atovaquone and Proguanil
Clinical summary
Atovaquone and Proguanil is a fixed-dose combination of an antimalarial and an antiprotozoal indicated for prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported, among other approved uses. MedsAcross supplies Atovaquone and Proguanil 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 Atovaquone and ProguanilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Atovaquone and Proguanil HCl prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
Need Malarone 250 mg/100 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.