Prescription medicine
Artesunate
Artesunate is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: artesunate labels on DailyMed; the NDA 213036 record on Drugs@FDA; every artesunate label on DailyMed.
Highlights of the record
no current FDA label; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- May 26, 2020 Artesunate, Amivas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 16, 2044 Artesunate injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest September 27, 2021; 1 more by firms not listed as its makers
Is there a generic for artesunate?
No generic artesunate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Artesunate injection, the last expiring on February 16, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2044 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has artesunate been recalled?
The FDA's Enforcement Report lists 2 recalls naming artesunate since 2015: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of artesunate and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 27, 2021 | Class II | AMIVAS (US), LLC | Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance. |
| April 23, 2015 | Class II | South Coast Specialty Compounding, Inc. not a listed maker | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What next?
- Check an interaction
- what two or more labels say about each other