Dantrolene Sodium

Manages fulminant hypermetabolism of skeletal muscle characteristic of malignant…. Sold as Dantrium, Ryanodex. Every FDA application for this active ingredient: 3 branded and 5 generic.

As of Nov 15, 2026, FDA lists 8 applications for Dantrolene Sodium (sold as Dantrium, Ryanodex), first approved Jan 15, 1974, with 2 new uses approved and 0 published complete response letters.

First approved: Jan 15, 1974
Applications: 8
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $3.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Dantrolene Sodium	Part D	$3.6M	+1%	6,867
Dantrium	Part D	$4K	-46%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DANTROLENE SODIUM 100 MG CAP: $1.03 per unitGeneric · +20% in a year
DANTROLENE SODIUM 25 MG CAP: $0.405 per unitGeneric · +1% in a year
DANTROLENE SODIUM 50 MG CAP: $0.539 per unitGeneric · -20% in a year

Orphan Designations (FDA)

4 designations, 0 approved for the designated use; see all orphan designations

Treatment of organophosphate exposureEagle Pharmaceuticals, Inc. · designated Dec 12, 2019
Treatment of Wolfram SyndromeWashington University in St. Louis · designated Feb 17, 2016
Treatment of heat strokeEagle Pharmaceuticals, Inc. · designated Sep 25, 2012
Treatment of the neuroleptic malignant syndrome.Norwich Eaton Pharmaceuticals · designated Dec 14, 1987

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Dantrolene in Statin-induced MyopathyStatins Induced Myopathy · Tanta University	Phase 2 / Phase 3	Not yet recruiting	May 13, 2025
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)Multiple Sclerosis · National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1 / Phase 2	Recruiting	Apr 12, 2017

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 15, 1974	DantriumNDA 17443 · New molecular entity	Ph Health	40	Marketed
Sep 19, 1979	DantriumNDA 18264 · New dosage form	Ph Health	22	Marketed
Mar 1, 2005	Dantrolene SodiumANDA 76856	Impax Labs	1	Marketed
Oct 24, 2005	Dantrolene SodiumANDA 76686	Elite Labs Inc	1	Marketed
Jul 24, 2007	RevontoANDA 78378	Uswm	5	Marketed
Jul 22, 2014	RyanodexNDA 205579 · New dosage form	Eagle Pharms	3	Marketed
Feb 18, 2016	Dantrolene SodiumANDA 205239	Eugia Pharma Speclts	0	Discontinued
Jun 19, 2017	Dantrolene SodiumANDA 204762	Hikma	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA