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Active ingredient

Dantrolene

27 finished FDA listings contain Dantrolene as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DANTROLENE SODIUM
Dosage forms
Capsule, Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Suspension
Routes
Intravenous, Oral
Manufacturers / labelers
13
Strengths listed
100 mg/1 · 20 mg/1 · 20 mg/60ml · 25 mg/1 · 250 mg/5ml · 50 mg/1
Brand names in FDA listings
Dantrium, Revonto, Ryanodex Dantrolene Sodium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3105

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 017443PH HEALTH1974-01-159
NDA 018264PH HEALTH1979-09-191
ANDA 076856IMPAX LABS2005-03-017
ANDA 076686ELITE LABS INC2005-10-246
ANDA 078378USWM2007-07-242
NDA 205579EAGLE PHARMS2014-07-221
ANDA 204762HIKMA2017-06-191

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.