Medicine
Coartem 20 mg/120 mg tablet
Coartem 20 mg/120 mg tablet is a prescription medicine containing Artemether and Lumefantrine for oral use, marketed by Novartis Pharmaceuticals, 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 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC…
Key facts
- Active ingredient (INN)
- Artemether and Lumefantrine
- Brand
- Coartem
- Strength
- 20 mg/120 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 24 tablets
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01BF01 Artemether and Lumefantrine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 April 2009
- Identifiers
- RxCUI 847731, 847734DailyMed set ID 7866ec19-dfac-47d4-a53f-511a12643cbfNDC 0078-0568Application NDA022268
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 |
|---|---|---|---|
| 24 tablet in 1 bottle | 0078-0568-45 | Novartis Pharmaceuticals | 7 April 2009 |
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 7 April 2009 | 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
Clinical summary
Artemether and Lumefantrine is a fixed-dose combination medicine indicated for treatment of acute, among other approved uses. MedsAcross supplies Artemether and Lumefantrine 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 Artemether and LumefantrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- COARTEM prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Coartem 20 mg/120 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.