Quick answers
- What is Dantrolene sodium used for?
- The FDA-approved label (Dantrium, Par Health USA, LLC, August 25, 2026) says: “In Chronic Spasticity: Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dantrolene sodium have a boxed warning?
- Yes. The FDA label for Dantrium has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dantrolene sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dantrolene sodium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dantrolene sodium?
- 13 companies list prescription products of Dantrolene sodium in the FDA NDC Directory, including Bryant Ranch Prepack, Par Health USA, LLC and Elite Laboratories, Inc..
What Dantrolene sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
In Chronic Spasticity: Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. …
— FDA label: Dantrium, Par Health USA, LLC, effective August 25, 2026. Read the full label on DailyMed →
The FDA has 19 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
14 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Injection, powder, lyophilized, for solution · Injection · Injection, powder, for solution · Injection, suspension |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Revonto, Dantrium, Ryanodex Dantrolene Sodium |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dantrolene sodium 100 mg capsule | Generic | $1.03 per capsule |
| dantrolene sodium 25 mg capsule | Generic | $0.4048 per capsule |
| dantrolene sodium 50 mg capsule | Generic | $0.5391 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack6 products
- Par Health USA, LLC5 products
- Elite Laboratories, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Remedyrepack Inc.2 products
- Major Pharmaceuticals1 product
- ProPharma Distribution1 product
- Cardinal Health 107, LLC1 product
- American Health Packaging1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Eagle Pharmaceuticals, Inc.1 product
- AvPAK1 product
- Uswm, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017443 DANTRIUM | Ph Health | January 15, 1974 | 40, latest July 8, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2012: Labeling |
| NDA018264 DANTRIUM | Ph Health | September 19, 1979 | 22, latest April 2, 2024 2024: Labeling · 2008: Labeling · 2001: Labeling |
| NDA205579 RYANODEX | Eagle Pharms | July 22, 2014 | 3, latest April 2, 2024 2024: Labeling · 2020: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (4)
- ANDA076856Impax Labs · March 1, 2005
- ANDA076686Elite Labs Inc · October 24, 2005
- ANDA078378Uswm · July 24, 2007
- ANDA204762Hikma · June 19, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dantrium, Par Health USA, LLC, effective August 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →