Dantrium dantrolene sodium 25 mg Capsule, 100-count — NDC 42023-124-01 (Billing 42023-0124-01)
This is a package of 100 capsules of Dantrium dantrolene sodium 25 mg Capsule from Par Health USA, LLC, marketed since Aug 2008 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 42023-124-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 42023 labeler · 124 product · 01 package
- Package marketed since
- Aug 1, 2008
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC)
- 0342023126016, 0342023124012, 0342023125019
- FDA record last changed
- Sep 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004667
- GCN: 17941
- HICL (First Databank): 001947
- AHFS class code: 12:20.08.00
- RxCUI (RxNorm): 856652
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Skeletal Muscle Relaxant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Dantrolene is used to treat spasticity (muscle stiffness and tightness) or muscle spasms associated with spinal cord injuries, stroke, multiple sclerosis, or cerebral palsy. It is also used to prevent, treat, or reduce the risk of malignant hyperthermia (disorder that causes a fast rise in body temperature and muscle contractions), Dantrolene is in a class of medications called skeletal muscle relaxants. Dantrolene acts on the spinal cord nerves to treat spasticity and to prevent and treat malignant hyperthermia.
Read the full MedlinePlus article ↗- Dantrolene is used for two main things. If you're taking the capsules (Dantrium or Dantrolene Sodium), it's most likely to help control muscle stiffness and spasms caused by condit...
- The most serious risk is liver damage. Watch for yellowing of your skin or the whites of your eyes, very dark urine, persistent nausea, or pain in the upper right side of your abdo...
- What are the most important side effects I should watch for?
- Dantrolene can cause liver damage — and this is the number one safety concern with long-term use. Regular blood tests (liver function tests) are the only way to catch a problem ear...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dantrolene Sodium — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.05 | $105.38 / 100 capsules |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 42023-0124-01 You're viewing this Main listing | 100 CAPSULE in 1 BOTTLE | 2008-08-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dantrolene Sodium 25 mg 00115-4411-01 | Amneal | 100 capsules | $0.409 | AB | Availability likely | — |
| Dantrolene Sodium 25 mg 00904-7211-04 | Major | 30 capsules | $0.409 | AB | Availability likely | — |
| dantrolene sodium 25 mg 49884-0362-01 | Par | 100 capsules | $0.409 | AB | Availability likely | — |
| Dantrolene Sodium 25 mg 50268-0217-15 | AvPAK | 50 capsules | $0.409 | AB | Availability likely | — |
| Dantrolene Sodium 25 mg 64850-0840-01 | Elite | 100 capsules | $0.409 | AB | Availability likely | — |
| Dantrolene Sodium 25 mg 68084-0300-21 | American | 30 capsules | $0.409 | AB | Availability likely | — |
| Dantrium 25 mgthis 42023-0124-01 | Par | 100 capsules | — | AB | FDA listed | — |
| Dantrolene Sodium 25 mg 55154-7140-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| dantrolene sodium 25 mg 63629-2168-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| dantrolene sodium 25 mg 72162-1497-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| Dantrolene Sodium 25 mg 72162-2045-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Par Health USA, LLC labeler code 42023
- Ketalar ketamine hydrochloride 10 mg/mL Injection NDC 42023-113-10
- Ketalar ketamine hydrochloride 50 mg/mL Injection NDC 42023-114-10
- Ketalar ketamine hydrochloride 100 mg/mL Injection NDC 42023-115-10
- Pitocin oxytocin 10 [iU]/mL Injection NDC 42023-116-02
- Tigan trimethobenzamide hydrochloride 100 mg/mL Injection NDC 42023-119-25
- Dantrium dantrolene sodium 20 mg/60mL Injection NDC 42023-123-06
- Fluphenazine Decanoate 25 mg/mL Injection, Solution NDC 42023-129-01
- Pitocin oxytocin 10 [iU]/mL Injection NDC 42023-130-06
- Dexmedetomidine Hydrochloride 100 ug/mL Injection, Solution, Concentrate NDC 42023-146-25
- ETHACRYNATE SODIUM 50 mg/50mL Injection, Powder, For Solution NDC 42023-157-01
- Adrenalin epinephrine 1 mg/mL Injection NDC 42023-159-25
- Vasostrict Vasopressin 20 [USP'U]/mL Injection NDC 42023-164-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Dantrium (dantrolene sodium) has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day.
Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to Dantrium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy.
The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to Dantrium (dantrolene sodium). Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving Dantrium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection).
Dantrium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of Dantrium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function.
Dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without Dantrium. Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrium therapy.
In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of Dantrium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of Dantrium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful and/or disabling spasticity such as clonus, or permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
In Malignant Hyperthermia: Oral Dantrium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous dantrolene sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous.
Oral Dantrium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For Use in Chronic Spasticity: Prior to the administration of Dantrium , consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with Dantrium . Refer to INDICATIONS AND USAGE section for description of response to be anticipated.
It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning Dantrium therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated.
Usual Dosage: It is important that the dosage be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended. In view of the potential for liver damage in long-term Dantrium use, therapy should be stopped if benefits are not evident within 45 days.
Adults: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response.
If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose. 25 mg once daily for seven days, then 25 mg t.i.d. for seven days 50 mg t.i.d. for seven days 100 mg t.i.d. Therapy with a dose four times daily may be necessary for some individuals.
Doses higher than 100 mg four times daily should not be used. (See Box Warning . ) Pediatric Patients: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved.
Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose. 0.5 mg/kg once daily for seven days, then 0.5 mg/kg t.i.d. for seven days 1 mg/kg t.i.d. for seven days 2 mg/kg t.i.d.
Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used. (See Box Warning . ) For Malignant Hyperthermia: Preoperatively: Administer 4 to 8 mg/kg/day of oral Dantrium in 3 or 4 divided doses for one or two days prior to surgery, with the last dose being given approximately 3 to 4 hours before scheduled surgery with a minimum of water.
This dosage will usually be associated with skeletal muscle weakness and sedation (sleepiness or drowsiness); adjustment can usually be made within the recommended dosage range to avoid incapacitation or excessive gastrointestinal irritation (including nausea and/or vomiting). Post Crisis Follow-up: Oral Dantrium should also be administered following a malignant hyperthermia crisis, in doses of 4 to 8 mg/kg per day in four divided doses, for a one to three day period to prevent recurrence of the manifestations of malignant hyperthermia.
⛔ Contraindications ▾
CONTRAINDICATIONS Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of Dantrium . Dantrium is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function.
⚠️ Warnings ▾
WARNINGS It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium therapy. At the start of Dantrium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease. If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for Dantrium hepatotoxicity could be enhanced, although such a possibility has not yet been established.
Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during Dantrium therapy. If such studies reveal abnormal values, therapy should generally be discontinued. Only where benefits of the drug have been of major importance to the patient, should reinitiation or continuation of therapy be considered.
Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, Dantrium should be discontinued. If caused by Dantrium and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued.
Dantrium therapy has been reinstituted in a few patients who have developed clinical and/or laboratory evidence of hepatocellular injury. If such reinstitution of therapy is done, it should be attempted only in patients who clearly need Dantrium and only after previous symptoms and laboratory abnormalities have cleared. The patient should be hospitalized and the drug should be restarted in very small and gradually increasing doses.
Laboratory monitoring should be frequent and the drug should be withdrawn immediately if there is any indication of recurrent liver involvement. Some patients have reacted with unmistakable signs of liver abnormality upon administration of a challenge dose, while others have not. Dantrium should be used with particular caution in females and in patients over 35 years of age in view of apparent greater likelihood of drug-induced, potentially fatal, hepatocellular disease in these groups.
Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving Dantrium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term safety of Dantrium in humans has not been established.
Chronic studies in rats, dogs, and monkeys at dosages greater than 30 mg/kg/day showed growth or weight depression and signs of hepatopathy and possible occlusion nephropathy, all of which were reversible upon cessation of treatment. Sprague-Dawley female rats fed dantrolene sodium for 18 months at dosage levels of 15, 30, and 60 mg/kg/day showed an increased incidence of benign and malignant mammary tumors compared with concurrent controls. At the highest dose level, there was an increase in the incidence of benign lymphatic neoplasms.
In a 30-month study at the same dose levels also in Sprague-Dawley rats, dantrolene sodium produced a decrease in the time of onset of mammary neoplasms. Female rats at the highest dose level showed an increased incidence of hepatic lymphangiomas and hepatic angiosarcomas. The only drug-related effect seen in a 30-month study in Fischer-344 rats was a dose-related reduction in the time of onset of mammary and testicular tumors.
A 24-month study in HaM/ICR mice revealed no evidence of carcinogenic activity. Carcinogenicity in humans cannot be fully excluded, so that this possible risk of chronic administration must be weighed against the benefits of the drug (i.e., after a brief trial) for the individual patient. Dantrolene sodium has produced positi… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequently occurring side effects of Dantrium have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of Dantrium therapy.
If diarrhea recurs upon readministration of Dantrium , therapy should probably be withdrawn permanently. Other less frequent side effects, listed according to system, are: Gastrointestinal: Constipation, rarely progressing to signs of intestinal obstruction, GI bleeding, anorexia, swallowing difficulty, gastric irritation, abdominal cramps, nausea and/or vomiting. Hepatobiliary: Hepatitis (see WARNINGS ).
Neurologic: Speech disturbance, seizure, headache, light-headedness, visual disturbance, diplopia, alteration of taste, insomnia, drooling. Cardiovascular: Tachycardia, erratic blood pressure, phlebitis, heart failure. Hematologic: Aplastic anemia, anemia, leukopenia, lymphocytic lymphoma, thrombocytopenia.
Psychiatric: Mental depression, mental confusion, increased nervousness. Urogenital: Increased urinary frequency, crystalluria, hematuria, difficult erection, urinary incontinence and/or nocturia, difficult urination and/or urinary retention. Integumentary: Abnormal hair growth, acne-like rash, pruritus, urticaria, eczematoid eruption, sweating.
Musculoskeletal: Myalgia, backache. Respiratory: Feeling of suffocation, respiratory depression. Special Senses: Excessive tearing.
Hypersensitivity: Pleural effusion with pericarditis, pleural effusion with associated eosinophilia, anaphylaxis. Other: Chills and fever. The published literature has included some reports of Dantrium use in patients with Neuroleptic Malignant Syndrome (NMS).
Dantrium capsules are not indicated for the treatment of NMS and patients may expire despite treatment with Dantrium capsules. For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Health, at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions: Drowsiness may occur with Dantrium therapy, and the concomitant administration of CNS depressants such as sedatives and tranquilizing agents may result in further drowsiness. While a definite drug interaction with estrogen therapy has not yet been established, caution should be observed if the two drugs are to be given concomitantly. Hepatotoxicity has occurred more often in women over 35 years of age receiving concomitant estrogen therapy.
Cardiovascular collapse in patients treated simultaneously with verapamil and dantrolene sodium is rare. The combination of therapeutic doses of intravenous dantrolene sodium and verapamil in halothane/α-chloralose anesthetized swine has resulted in ventricular fibrillation and cardiovascular collapse in association with marked hyperkalemia. Until the relevance of these findings to humans is established, the combination of dantrolene sodium and calcium channel blockers is not recommended during the management of malignant hyperthermia.
Administration of Dantrium may potentiate vecuronium-induced neuromuscular block.
🤰 Pregnancy ▾
Pregnancy: Adequate animal reproduction studies have not been conducted with Dantrium . It is also not known whether Dantrium can cause fatal harm when administered to a pregnant woman or can affect reproduction capacity. Dantrium should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Usage in Pediatric Patients: The long-term safety of Dantrium in pediatric patients under the age of 5 years has not been established. Because of the possibility that adverse effects of the drug could become apparent only after many years, a benefit-risk consideration of the long-term use of Dantrium is particularly important in pediatric patients.
Pediatric Patients: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response.
If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose. 0.5 mg/kg once daily for seven days, then 0.5 mg/kg t.i.d. for seven days 1 mg/kg t.i.d. for seven days 2 mg/kg t.i.d. Therapy with a dose four times daily may be necessary for some individuals.
Doses higher than 100 mg four times daily should not be used. (See Box Warning . )
🧓 Geriatric Use ▾
Geriatric Use: Clinical studies of Dantrium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in the literature has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
As with all patients receiving Dantrium , it is recommended that elderly patients receive the lowest dose compatible with the optimal response. Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving Dantrium . However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (for hepatotoxicity details and its management see Black Box and Warnings Sections ).
🆘 Overdosage ▾
OVERDOSAGE Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g. lethargy, coma), vomiting, diarrhea, and crystalluria. For acute overdose, general supportive measures should be employed along with immediate gastric lavage. Intravenous fluids should be administered in fairly large quantities to avert the possibility of crystalluria.
An adequate airway should be maintained and artificial resuscitation equipment should be at hand. Electrocardiographic monitoring should be instituted, and the patient carefully observed. To date, no experience has been reported with dialysis and its value in Dantrium overdose is not known.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY In isolated nerve-muscle preparation, Dantrium has been shown to produce relaxation by affecting the contractile response of the skeletal muscle at a site beyond the myoneural junction, directly on the muscle itself. In skeletal muscle, Dantrium dissociates the excitation-contraction coupling, probably by interfering with the release of Ca ++ from the sarcoplasmic reticulum. This effect appears to be more pronounced in fast muscle fibers as compared to slow ones, but generally affects both.
A central nervous system effect occurs, with drowsiness, dizziness, and generalized weakness occasionally present. Although Dantrium does not appear to directly affect the CNS, the extent of its indirect effect is unknown. The absorption of Dantrium after oral administration in humans is incomplete and slow but consistent, and dose-related blood levels are obtained.
The duration and intensity of skeletal muscle relaxation is related to the dosage and blood levels. The mean biologic half-life of Dantrium in adults is 8.7 hours after a 100-mg dose. Specific metabolic pathways in the degradation and elimination of Dantrium in human subjects have been established.
Metabolic patterns are similar in adults and pediatric patients. In addition to the parent compound, dantrolene, which is found in measurable amounts in blood and urine, the major metabolites noted in body fluids are the 5-hydroxy analog and the acetamido analog. Since Dantrium is probably metabolized by hepatic microsomal enzymes, enhancement of its metabolism by other drugs is possible.
However, neither phenobarbital nor diazepam appears to affect Dantrium metabolism. Clinical experience in the management of fulminant human malignant hyperthermia, as well as experiments conducted in malignant hyperthermia susceptible swine, have revealed that the administration of intravenous dantrolene, combined with indicated supportive measures, is effective in reversing the hypermetabolic process of malignant hyperthermia. Known differences between human and swine malignant hyperthermia are minor.
The prophylactic administration of oral or intravenous dantrolene to malignant hyperthermia susceptible swine will attenuate or prevent the development of signs of malignant hyperthermia in a manner dependent upon the dosage of dantrolene administered and the intensity of the malignant hyperthermia triggering stimulus. Limited clinical experience with the administration of oral dantrolene to patients judged malignant hyperthermia susceptible, when combined with clinical experience in the use of intravenous dantrolene for the treatment of malignant hyperthermia and data derived from the above cited animal model experiments, suggests that oral dantrolene will also attenuate or prevent the development of signs of human malignant hyperthermia, provided that currently accepted practices in the management of such patients are adhered to (see INDICATIONS AND USAGE ); intravenous dantrolene should also be available for use should the signs of malignant hyperthermia appear.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Dantrium (dantrolene sodium) is available in: 25-mg opaque, orange and tan capsules imprinted with DANTRIUM 25 mg on the cap and 0149 0030 with a single bar on the body. NDC 42023-124-01 bottle of 100 50-mg opaque, orange and tan capsules imprinted with DANTRIUM 50 mg on the cap and 0149 0031 with a double bar on the body. NDC 42023-125-01 bottle of 100 100-mg opaque, orange and tan capsules imprinted with DANTRIUM 100 mg on the cap and 0149 0033 with a triple bar on the body.
NDC 42023-126-01 bottle of 100 Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION The chemical formula of Dantrium (dantrolene sodium) is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility increases somewhat in alkaline solution. The anhydrous salt has a molecular weight of 336.
The hydrated salt contains approximately 15% water (3-1/2 moles) and has a molecular weight of 399. The structural formula for the hydrated salt is: Dantrium is supplied in capsules of 25 mg, 50 mg, and 100 mg. Inactive Ingredients: Each capsule contains Edible black ink, FD&C Yellow No.
6, Gelatin, Lactose, Magnesium stearate, Starch, Synthetic iron oxide red, Synthetic iron oxide yellow, Talc, and Titanium dioxide. Dantrolene sodium chemical structure
💬 Information for Patients ▾
Information for Patients: Patients should be cautioned against driving a motor vehicle or participating in hazardous occupations while taking Dantrium . Caution should be exercised in the concomitant administration of tranquilizing agents. Dantrium might possibly evoke a photosensitivity reaction; patients should be cautioned about exposure to sunlight while taking it.
⚠️ Precautions ▾
PRECAUTIONS Dantrium should be used with caution in patients with impaired pulmonary function, particularly those with obstructive pulmonary disease, and in patients with severely impaired cardiac function due to myocardial disease. Dantrium is associated with pleural effusion with associated eosinophilia. It should be used with caution in patients with a history of previous liver disease or dysfunction (see WARNINGS ).
Information for Patients: Patients should be cautioned against driving a motor vehicle or participating in hazardous occupations while taking Dantrium . Caution should be exercised in the concomitant administration of tranquilizing agents. Dantrium might possibly evoke a photosensitivity reaction; patients should be cautioned about exposure to sunlight while taking it.
🍼 Nursing Mothers ▾
Nursing Mothers: Dantrium should not be used in nursing mothers.
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Drug abuse and dependency potential has not been evaluated in human or animal studies.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term safety of Dantrium in humans has not been established. Chronic studies in rats, dogs, and monkeys at dosages greater than 30 mg/kg/day showed growth or weight depression and signs of hepatopathy and possible occlusion nephropathy, all of which were reversible upon cessation of treatment. Sprague-Dawley female rats fed dantrolene sodium for 18 months at dosage levels of 15, 30, and 60 mg/kg/day showed an increased incidence of benign and malignant mammary tumors compared with concurrent controls.
At the highest dose level, there was an increase in the incidence of benign lymphatic neoplasms. In a 30-month study at the same dose levels also in Sprague-Dawley rats, dantrolene sodium produced a decrease in the time of onset of mammary neoplasms. Female rats at the highest dose level showed an increased incidence of hepatic lymphangiomas and hepatic angiosarcomas.
The only drug-related effect seen in a 30-month study in Fischer-344 rats was a dose-related reduction in the time of onset of mammary and testicular tumors. A 24-month study in HaM/ICR mice revealed no evidence of carcinogenic activity. Carcinogenicity in humans cannot be fully excluded, so that this possible risk of chronic administration must be weighed against the benefits of the drug (i.e., after a brief trial) for the individual patient.
Dantrolene sodium has produced positive results in the Ames S. Typhimurium bacterial mutagenesis assay in the presence and absence of a liver activating system.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label NDC 42023- 124 -01 25 mg Dantrium ® (dantrolene sodium) PERIPHERAL SKELETAL MUSCLE RELAXANT 100 Capsules Rx only 25 mg- 100 Capsules
PRINCIPAL DISPLAY PANEL - 50 mg Bottle Label NDC 42023- 125 -01 50 mg Dantrium ® (dantrolene sodium) PERIPHERAL SKELETAL MUSCLE RELAXANT 100 Capsules Rx only Dantrium-50mg-label.jpg
PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label NDC 42023- 126 -01 100 mg Dantrium ® (dantrolene sodium) PERIPHERAL SKELETAL MUSCLE RELAXANT 100 Capsules Rx only Dantrium-100mg.jpg
Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |