Quick answers
- What is Revonto?
- Revonto is a brand name of Dantrolene sodium, a prescription medicine. The FDA NDC Directory lists 2 Revonto products in 1 strength and form.
- Who makes Revonto?
- Uswm holds the FDA application for Revonto (ANDA078378, approved July 24, 2007). 1 other company (repackagers or distributors) also list Revonto products.
- Is there a generic or store brand of Revonto?
- Other products of Dantrolene sodium are listed with the FDA, but none in exactly the same strength and form as a Revonto product.
- Has Revonto been recalled?
- FDA enforcement reports list 1 recall of Revonto products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What Revonto is
Each Revonto 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.
Dantrolene sodium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dantrolene sodium 20 mg/60 mL injection, powder, lyophilized, for solution (intravenous) | Revonto | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dantrolene sodium →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA078378 | Uswm | July 24, 2007 | 2 |
Companies that list Revonto
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Revonto products.
- ProPharma Distribution1 product
- Uswm, LLC1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1081-2022
cGMP deviations: Temperature abuse
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67 — Mckesson Medical-Surgical Inc. Corporate Office
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.