Quick answers
- What is Kimyrsa?
- Kimyrsa is a brand name of Oritavancin, a prescription medicine. The FDA NDC Directory lists 1 Kimyrsa product in 1 strength and form.
- Who makes Kimyrsa?
- Melinta Therap holds the FDA application for Kimyrsa (NDA214155, approved March 12, 2021).
- Is there a generic or store brand of Kimyrsa?
- Other products of Oritavancin are listed with the FDA, but none in exactly the same strength and form as a Kimyrsa product.
- Has Kimyrsa been recalled?
- No recall linked to Kimyrsa products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Kimyrsa is
Each Kimyrsa product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Oritavancin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| oritavancin diphosphate 1200 mg/40 mL injection, powder, lyophilized, for solution (intravenous) | Kimyrsa | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Oritavancin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA214155 | Melinta Therap | March 12, 2021 | 1 |
Companies that list Kimyrsa
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Kimyrsa products.
- Melinta Therapeutics, LLC1 product
Recalls
No recall linked to Kimyrsa products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.