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RYANODEX dantrolene sodium 250 mg/5mL Injection, Suspension — NDC 42367-0540-32 package photo
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RYANODEX dantrolene sodium 250 mg/5mL Injection, Suspension — NDC 42367-540-32 (Billing 42367-0540-32)

by Eagle Pharmaceuticals, Inc. · 1 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of RYANODEX dantrolene sodium 250 mg/5mL Injection, Suspension from Eagle Pharmaceuticals, Inc., marketed since Jul 2014 and currently FDA-listed. It is this product's only package size.

NDC 42367-0540-32
🏷️ FDA NDC (as labeled) 42367-540-32 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42367-540-32
Product NDC 42367-540
11-digit billing NDC 42367054032
NCPDP billing unit EA — each (per item)
RxCUI 1544753, 1544758
UNII 287M0347EV
UPC 0342367540325
Application # NDA205579
SPL Set ID 8f7b3ac0-604d-4c78-b545-5e0f8ea3d698
Established class (EPC) Skeletal Muscle Relaxant
Physiologic effect Decreased Striated Muscle Contraction; Decreased Striated Muscle Tone
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-07-23
Route INTRAVENOUS
Dosage form INJECTION, SUSPENSION
Substance DANTROLENE SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 75200010101920
GPI class Ryanodex
GCN Seq No 072636
GCN 36908
HICL code 001947
Ingredient (HICL) Dantrolene Sodium
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.08.00
AHFS class Direct-Acting Skeletal Muscle Relaxants
FDB label name RYANODEX 250 MG VIAL
FDB brand name Ryanodex
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 072636
  • GCN: 36908
  • GPI-14 (Medi-Span): 75200010101920
  • HICL (First Databank): 001947
  • AHFS class code: 12:20.08.00
  • RxCUI (RxNorm): 1544753
Why two NDCs? The FDA registers this code as 42367-540-32 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42367-0540-32. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Skeletal Muscle Relaxant class.

Pharmacologic class Skeletal Muscle Relaxant
Drug family (ATC) Dantrolene and derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RYANODEX 250 MG VIAL Ingredient Dantrolene Sodium
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Dantrolene guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
42367-0540-32 You're viewing this Main listing 1 VIAL in 1 CARTON / 20 mL in 1 VIAL 2014-07-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
RYANODEX dantrolene sodium 250 mg/5mLthis 42367-0540-32 Eagle 1 vial — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Jul 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 333AG72FWJ
    Povidone K12 is a synthetic polymer derived from petroleum. It acts as a binder and disintegrant in tablets and capsules, helping hold ingredients together and allowing the tablet to break apart for absorption.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEagle Pharmaceuticals, Inc.
Application holderEAGLE PHARMACEUTICALS INC
FDA applicationNDA205579 (NDA)
Labeler code42367
First marketedJul 2014
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 70 words ▾

1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Treatment of Malignant Hyperthermia (MH) ( 2.1 ) Administer by intravenous push at a minimum of 1 mg/kg. If signs continue, administer additional intravenous boluses up to maximum cumulative dosage of 10 mg/kg. Institute supportive measures (e.g., discontinue MH-triggering agents, manage metabolic acidosis, cooling if necessary, administer diuretics) Prevention of MH in Patients at High Risk ( 2.2 ) Administer 2.5 mg/kg intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery.

Avoid agents that trigger MH. Administer additional individualized doses during anesthesia and surgery if surgery is prolonged. Pediatric Patients : recommended weight-based dose is the same as for adults ( 2.3 ) Reconstitution : With 5 mL of sterile water for injection (without a bacteriostatic agent) prior to administration ( 2.4 )

2.1Dosage for Treatment of Malignant Hyperthermia In addition to RYANODEX treatment, institute the following supportive measures: Discontinue use of malignant hyperthermia (MH)-triggering anesthetic agents (i.e., volatile anesthetic gases and succinylcholine). Manage the metabolic acidosis Institute cooling when necessary Administer diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX is insufficient to maintain diuresis) [see Description ( 11 )] Administer RYANODEX by intravenous push at a minimum dose of 1 mg/kg.

If the physiologic and metabolic abnormalities of MH continue, administer additional intravenous boluses up to the maximum cumulative dosage of 10 mg/kg. If the physiologic and metabolic abnormalities reappear, repeat RYANODEX dosing by intravenous push starting with 1 mg/kg.

2.2Dosage for Prevention of Malignant Hyperthermia The recommended prophylactic dose of RYANODEX is 2.5 mg/kg administered intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery. Avoid agents that trigger MH. If surgery is prolonged, administer additional individualized RYANODEX doses during anesthesia and surgery [see Clinical Pharmacology ( 12.3 )].

2.3Dosage for Pediatric Patients The recommended weight-based dose of RYANODEX for pediatric patients in the treatment and prevention of MH is the same as for adults for these indications [see Dosage and Administration ( 2.1 , 2.2 )].

2.4Reconstitution and Administration Instructions The supplied lyophilized powder must be reconstituted prior to administration: (a) Reconstitute each vial of RYANODEX lyophilized powder by adding 5 mL of sterile water for injection (without a bacteriostatic agent). Do not reconstitute with any other solution (e.g., 5% dextrose injection, 0.9% sodium chloride injection). (b) Shake the vial to ensure an orange-colored uniform suspension.

Visually inspect the vial for particulate matter and discoloration prior to administration. (c) Must use the contents of the vial within 6 hours after reconstitution. Store reconstituted suspensions at controlled room temperature (68°F to 77°F or 20°C to 25°C).

Do not dilute or transfer the reconstituted RYANODEX suspension to another container to infuse the product. Administer the reconstituted RYANODEX suspension either: Into the intravenous catheter while an intravenous infusion of 0.9% sodium chloride injection, or 5% dextrose injection is freely running; or Into the indwelling catheter - after assuring its patency - without a freely running infusion. Flush the line to assure that there is no residual RYANODEX remaining in the catheter [see Warnings and Precautions ( 5.3 )].

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS For injectable suspension: RYANODEX is a sterile, lyophilized powder containing 250 mg of dantrolene sodium for reconstitution, in single-dose vials For injectable suspension: 250 mg of lyophilized powder in a single-dose vial for reconstitution ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Skeletal Muscle Weakness : Ambulate patients with assistance until they have normal strength and balance ( 5.1 ) Dyspnea, Respiratory Muscle Weakness, and Decreased Inspiratory Capacity : Monitor patients for the adequacy of ventilation ( 5.1 ) Dysphagia : Assess patients for difficulty swallowing and choking ( 5.1 ) Somnolence and Dizziness : Can occur following RYANODEX administration; may persist up to 48 hours post-dose. Ambulate patients with assistance until they have normal strength and balance ( 5.2 ) Tissue Necrosis with Extravasation : Due to high pH of reconstituted RYANODEX for injectable suspension, care must be taken to prevent extravasation into surrounding tissues ( 5.3 )

5.1Muscle Weakness RYANODEX is associated with skeletal muscle weakness. The administration of RYANODEX in human volunteers has been associated with loss of grip strength and weakness in the legs. Patients should not be permitted to ambulate without assistance until they have normal strength and balance.

RYANODEX has been associated with dyspnea, respiratory muscle weakness, and decreased inspiratory capacity. Monitor patients for the adequacy of ventilation. RYANODEX has been associated with dysphagia.

Assess patients for difficulty swallowing and choking.

5.2Somnolence and Dizziness Somnolence and dizziness can occur following administration of RYANODEX and may persist up to 48 hours post-dose. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Patients must not operate an automobile or engage in other hazardous activities for 48 hours post-dose. The concomitant use of sedative agents with RYANODEX may increase the risk of somnolence and dizziness.

5.3Potential for Tissue Necrosis with Extravasation Care must be taken to prevent extravasation of RYANODEX into the surrounding tissues due to the high pH of the reconstituted RYANODEX suspension and potential for tissue necrosis.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Administration to conscious subjects is associated with loss of grip strength and weakness in the legs, drowsiness and dizziness. Other common adverse reactions are: nausea, thrombophlebitis, tissue necrosis secondary to extravasation, urticaria and erythema, and injection site reactions (pain, erythema, swelling) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eagle at 1-855-318-2170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a study designed to evaluate the safety and tolerability of RYANODEX, healthy volunteers were randomly assigned to receive treatment with RYANODEX or an active comparator at doses ranging from 1 mg/kg to 2.5 mg/kg. The RYANODEX dose was infused over the course of 1 minute for each of the doses evaluated.

The active comparator was an injectable formulation of dantrolene sodium that differed from RYANODEX in that it contained dantrolene sodium and mannitol at concentrations of 0.33 mg/mL and 50 mg/mL, respectively, when reconstituted according to the product's prescribing information. The active comparator was infused at a rate that administered 20 mg of dantrolene per minute for each of the doses evaluated. Table 1 displays the most common adverse events in this study.

These data are not an adequate basis for comparison of the types or frequencies of adverse event types between RYANODEX and the dantrolene sodium comparator. Adverse events increased in frequency with increasing doses in the trial, but did not differ in frequency between the two treatment groups. RYANODEX-treated subjects were more likely to report immediate adverse events of flushing, dystonia, and dysphagia than those receiving the active comparator.

In all dose groups, hand grip strength declined after dosing. In general, the decline in hand grip strength was more pronounced and occurred more rapidly in the RYANODEX-treated subjects in the 1.0, 1.75, 2.0 and 2.25 mg/kg treatment groups. In the 2.5 mg/kg treatment group, the decline in hand grip strength both in amount and duration was similar between the two treatment groups.

Table 1: Adverse Events in Healthy Volunteers Number of subjects (%) RYANODEX [N=30] n (%) Dantrolene Sodium Comparator [N=31] n (%) Flushing 8 (27) 1 (3) Somnolence 5 (17) 4 (13) Dysphonia 4 (13) 1 (3) Dysphagia 3 (10) 4 (13) Nausea 3 (10) 3 (10) Feeling abnormal 3 (10) 3 (10) Headache 1 (3) 4 (13) Vomiting 1 (3) 2 (6) Vision blurred 1 (3) 1 (3) Pain in extremity 1 (3) 1 (3) Muscular weakness/Asthenia 1 (3) 1 (3) Atrioventricular block 1 (3) 0 Tachycardia 1 (3) 0 Infusion site pain 1 (3) 0 Dizziness 1 (3) 0

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of another formulation of dantrolene sodium for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Pulmonary Edema There have been reports of pulmonary edema developing during the treatment of malignant hyperthermia crises with another dantrolene sodium dosage form.

The contributory effect of the diluent volume and mannitol in these cases is not known. Thrombophlebitis and Tissue Necrosis There have been reports of thrombophlebitis following administration of intravenous dantrolene. Tissue necrosis secondary to extravasation has been reported [see Warnings and Precautions ( 5.3 )].

Hypersensitivity/Anaphylactic Reactions There have been reports of urticaria and erythema possibly associated with the administration of dantrolene sodium for injection. Anaphylaxis has been reported. Injection Site Reactions Injection site react… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 140 words ▾

7 DRUG INTERACTIONS Calcium Channel Blockers : Concomitant use can cause cardiovascular collapse in association with marked hyperkalemia ( 7.1 ) Muscle Relaxants : Concomitant use with muscle relaxants may potentiate their effects ( 7.2 ) Sedatives : Concomitant use with sedative agents may potentiate their effects ( 7.3 )

7.1Calcium Channel Blockers Cardiovascular collapse in association with marked hyperkalemia has been reported in patients receiving dantrolene in combination with calcium channel blockers. The concomitant use of RYANODEX and calcium channel blockers is not recommended during the treatment of malignant hyperthermia.

7.2Muscle Relaxants The concomitant administration of RYANODEX with muscle relaxants may potentiate the neuromuscular block.

7.3Antipsychotics and Antianxiety Agents The concomitant administration of RYANODEX with antipsychotic and antianxiety agents may potentiate their effects on the central nervous system [see Warnings and Precautions ( 5.2 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Based on animal data, may cause fetal harm); however, RYANODEX administration for malignant hyperthermia may be lifesaving for the pregnant woman and fetus. Treatment should not be withheld due to pregnancy ( 8.1 ) Lactation : Breastfeeding is not recommended during treatment with RYANODEX and for 3 days after the final dose. ( 8.2 )

8.1Pregnancy Risk Summary Available data from published case reports with RYANODEX use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Dantrolene readily crosses the placenta; however, no serious adverse events have been reported in the neonate following maternal administration of dantrolene prior to delivery. There are risks to the pregnant woman and fetus associated with untreated malignant hyperthermia ( see Clinical Considerations ).

In animal reproduction studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk Malignant hyperthermia is a medical emergency which can be fatal for the pregnant woman and fetus if left untreated. Life-sustaining therapy should not be withheld due to pregnancy.

Labor or Delivery In one uncontrolled study, 100 mg per day of prophylactic oral dantrolene sodium was administered to term pregnant patients awaiting labor and delivery. Dantrolene readily crossed the placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply. No neonatal respiratory and neuromuscular side effects were observed in this study.

Data Animal Data Animal reproduction studies have been conducted with dantrolene sodium. In these studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose.

8.2Lactation Risk Summary Dantrolene is reported to be present in human milk following intravenous administration over 3 days. There are no data on the effects on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed infant, including respiratory depression and muscle weakness, advise patients that breastfeeding is not recommended during treatment with RYANODEX, and for 3 days after the last dose.

Clinical Considerations A lactating woman should interrupt breastfeeding and pump and discard breast milk during treatment and for 3 days after RYANODEX administration.

8.4Pediatric Use The safety and efficacy of RYANODEX in the treatment and prevention of malignant hyperthermia in pediatric patients is based on clinical experience with other intravenous dantrolene sodium products, which suggests adult weight-based doses are appropriate for pediatric patients.

8.5Geriatric Use Clinical studies of RYANODEX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience 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.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data from published case reports with RYANODEX use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Dantrolene readily crosses the placenta; however, no serious adverse events have been reported in the neonate following maternal administration of dantrolene prior to delivery. There are risks to the pregnant woman and fetus associated with untreated malignant hyperthermia ( see Clinical Considerations ).

In animal reproduction studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk Malignant hyperthermia is a medical emergency which can be fatal for the pregnant woman and fetus if left untreated. Life-sustaining therapy should not be withheld due to pregnancy.

Labor or Delivery In one uncontrolled study, 100 mg per day of prophylactic oral dantrolene sodium was administered to term pregnant patients awaiting labor and delivery. Dantrolene readily crossed the placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply. No neonatal respiratory and neuromuscular side effects were observed in this study.

Data Animal Data Animal reproduction studies have been conducted with dantrolene sodium. In these studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose.

🧒 Pediatric Use 41 words ▾

8.4Pediatric Use The safety and efficacy of RYANODEX in the treatment and prevention of malignant hyperthermia in pediatric patients is based on clinical experience with other intravenous dantrolene sodium products, which suggests adult weight-based doses are appropriate for pediatric patients.

🧓 Geriatric Use 73 words ▾

8.5Geriatric Use Clinical studies of RYANODEX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience 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.

🆘 Overdosage 83 words ▾

10 OVERDOSAGE

10.1Overdosage Symptoms Overdosage symptoms include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea, and crystalluria.

10.2Management of Overdosage Employ general supportive measures for acute overdosage of RYANODEX. Administer intravenous fluids in fairly large quantities to avert the possibility of crystalluria. Maintain an adequate airway and keep artificial resuscitation equipment available. Institute electrocardiographic monitoring and carefully observe the patient. The value of dialysis in RYANODEX overdosage is not known.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In isolated nerve-muscle preparation, dantrolene has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, dantrolene dissociates the excitation-contraction coupling, probably by interfering with the release of Ca ++ from the sarcoplasmic reticulum. In the anesthetic-induced malignant hyperthermia syndrome, evidence points to an intrinsic abnormality of skeletal muscle tissue.

In affected humans, it has been postulated that “triggering agents” (e.g., general anesthetics and depolarizing neuromuscular blocking agents) produce a change within the cell which results in an elevated myoplasmic calcium. This elevated myoplasmic calcium activates acute cellular catabolic processes that cascade to the malignant hyperthermia crisis. The addition of dantrolene to the “triggered” malignant hyperthermic muscle cell may reestablish a normal level of ionized calcium in the myoplasm.

Inhibition of calcium release from the sarcoplasmic reticulum by dantrolene reestablishes the myoplasmic calcium equilibrium, increasing the percentage of bound calcium. In this way, physiologic, metabolic, and biochemical changes associated with the malignant hyperthermia crisis may be reversed or attenuated.

12.2Pharmacodynamics The administration of intravenous dantrolene to human volunteers was associated with loss of grip strength and weakness in the legs, as well as subjective CNS complaints [see Warnings and Precautions ( 5.1 )] .

12.3Pharmacokinetics The pharmacokinetics of RYANODEX was investigated in healthy volunteers following single-dose administration as an intravenous push over 60 seconds (dose range of 1 to 2.5 mg/kg), via a peripheral catheter. There was a dose-proportional increase in plasma exposure of dantrolene and its metabolite, 5-hydroxydantrolene. Table 2 presents pharmacokinetic parameters of dantrolene after administration of a single RYANODEX dose of 2.5 mg/kg.

Time to peak dantrolene concentration was observed at the first time point collected (i.e., median T max is 1 minute post-dose). The mean half-life (t 1/2 ) for dantrolene was independent of the RYANODEX dose administered and ranged from 8.5 hours to 11.4 hours over the 1 to 2.5 mg/kg dose range. Table 2: Pharmacokinetic Parameters for Dantrolene in Healthy Volunteers (Mean ± Standard Deviation) 1 n=15; single-dose RYANODEX dose 1 C max (μg/mL) AUC 0-inf (μg*h/mL) Half-life (hrs) Clearance (L/hr) Volume of distribution (L) 2.5 mg/kg 9.0 ± 4.6 77.7 ± 23.2 10.8 ± 2.2 2.5 ± 1.0 36.4 ±

11.7When prophylactic intravenous dantrolene infusion was administered, whole blood dantrolene concentrations remained at a near steady state level for 3 or more hours after the infusion was completed. Distribution Based on assays of whole blood and plasma, slightly greater amounts of dantrolene are associated with red blood cells than with the plasma fraction of blood. Significant amounts of dantrolene are bound to plasma proteins, mostly albumin, and this binding is readily reversible.

Binding to plasma protein is not significantly altered by diazepam, diphenylhydantoin, or phenylbutazone. Binding to plasma proteins is reduced by warfarin and clofibrate and increased by tolbutamide. Information concerning the passage of dantrolene across the blood-brain barrier is not available.

Metabolism Dantrolene is found in measurable amounts in blood and urine. Its major metabolites in body fluids are 5-hydroxy dantrolene and an acetylamino metabolite of dantrolene. Another metabolite with an unknown structure appears related to the latter.

Dantrolene may also undergo hydrolysis and subsequent oxidation forming nitrophenylfuroic acid. Following RYANODEX 2.5 mg/kg dose administration in healthy volunteers, mean peak plasma concentration for the primary metabolite, 5-hydroxydantrolene, was 640 ng/mL, and was achieved by approximately 24 hours post-dose, with an average… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 176 words ▾

12.1Mechanism of Action In isolated nerve-muscle preparation, dantrolene has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, dantrolene dissociates the excitation-contraction coupling, probably by interfering with the release of Ca ++ from the sarcoplasmic reticulum. In the anesthetic-induced malignant hyperthermia syndrome, evidence points to an intrinsic abnormality of skeletal muscle tissue.

In affected humans, it has been postulated that “triggering agents” (e.g., general anesthetics and depolarizing neuromuscular blocking agents) produce a change within the cell which results in an elevated myoplasmic calcium. This elevated myoplasmic calcium activates acute cellular catabolic processes that cascade to the malignant hyperthermia crisis. The addition of dantrolene to the “triggered” malignant hyperthermic muscle cell may reestablish a normal level of ionized calcium in the myoplasm.

Inhibition of calcium release from the sarcoplasmic reticulum by dantrolene reestablishes the myoplasmic calcium equilibrium, increasing the percentage of bound calcium. In this way, physiologic, metabolic, and biochemical changes associated with the malignant hyperthermia crisis may be reversed or attenuated.

📦 How Supplied / Storage and Handling 85 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING RYANODEX ® (NDC 42367-540-32) is available in 20 mL vials containing a sterile lyophilized mixture of 250 mg dantrolene sodium for reconstitution with 5 mL sterile water for injection USP (without a bacteriostatic agent) to yield an orange colored injectable suspension. Store unreconstituted product at 20 °C to 25 °C (68 ºF to 77 ºF) [see USP Controlled Room Temperature], with excursions permitted to 15 ºC to 30 ºC (59 ºF to 86 ºF) and avoid prolonged exposure to light.

📋 Description 127 words ▾

11 DESCRIPTION RYANODEX ® (dantrolene sodium) for injectable suspension is a sterile lyophilized powder. RYANODEX is supplied in 20 mL vials containing 250 mg dantrolene sodium and the following inactive ingredients: 125 mg mannitol, 25 mg polysorbate 80, 4 mg povidone K12 and sufficient sodium hydroxide or hydrochloric acid for pH adjustment. When reconstituted with 5 mL sterile water for injection USP (without a bacteriostatic agent), this yields a suspension with a pH of approximately 10.3.

RYANODEX is a skeletal muscle relaxant. Chemically, RYANODEX is a hydrate of 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione sodium salt. The structural formula for the hydrated salt is: The hydrated salt contains approximately 15% water (3-1/2 moles) and has a molecular weight of 399.

The anhydrous salt (dantrolene) has a molecular weight of 336. Structural Formula

💬 Information for Patients 209 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, their families, or their caregivers of the following: Muscle Weakness Muscle weakness (i.e., decrease in grip strength and weakness of leg muscles, especially walking down stairs) is likely to occur with the use of RYANODEX. Patients should be provided assistance with standing and walking until their strength has returned to normal [see Warnings and Precautions ( 5.1 )]. Difficulty Swallowing Caution is indicated at meals on the day of administration because difficulty swallowing and choking have occurred with the use of dantrolene sodium products in general; dysphagia has been reported with the use of RYANODEX [see Warnings and Precautions ( 5.1 )].

Dizziness and Somnolence The use of RYANODEX has been associated with dizziness and somnolence. [see Warnings and Precautions ( 5.2 )]. Driving or Operating Machinery Symptoms such as “lightheadedness” may occur. Since some of these symptoms may persist for up to 48 hours, patients must not operate an automobile or engage in other hazardous activity during this time [see Warnings and Precautions ( 5.2 )] .

Lactation Advise females not to breastfeed during treatment with RYANODEX and for 3 days after the final dose [see Use in Specific Populations ( 8.2 )]. Marketed by: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of RYANODEX was investigated in healthy volunteers following single-dose administration as an intravenous push over 60 seconds (dose range of 1 to 2.5 mg/kg), via a peripheral catheter. There was a dose-proportional increase in plasma exposure of dantrolene and its metabolite, 5-hydroxydantrolene. Table 2 presents pharmacokinetic parameters of dantrolene after administration of a single RYANODEX dose of 2.5 mg/kg.

Time to peak dantrolene concentration was observed at the first time point collected (i.e., median T max is 1 minute post-dose). The mean half-life (t 1/2 ) for dantrolene was independent of the RYANODEX dose administered and ranged from 8.5 hours to 11.4 hours over the 1 to 2.5 mg/kg dose range. Table 2: Pharmacokinetic Parameters for Dantrolene in Healthy Volunteers (Mean ± Standard Deviation) 1 n=15; single-dose RYANODEX dose 1 C max (μg/mL) AUC 0-inf (μg*h/mL) Half-life (hrs) Clearance (L/hr) Volume of distribution (L) 2.5 mg/kg 9.0 ± 4.6 77.7 ± 23.2 10.8 ± 2.2 2.5 ± 1.0 36.4 ±

11.7When prophylactic intravenous dantrolene infusion was administered, whole blood dantrolene concentrations remained at a near steady state level for 3 or more hours after the infusion was completed. Distribution Based on assays of whole blood and plasma, slightly greater amounts of dantrolene are associated with red blood cells than with the plasma fraction of blood. Significant amounts of dantrolene are bound to plasma proteins, mostly albumin, and this binding is readily reversible.

Binding to plasma protein is not significantly altered by diazepam, diphenylhydantoin, or phenylbutazone. Binding to plasma proteins is reduced by warfarin and clofibrate and increased by tolbutamide. Information concerning the passage of dantrolene across the blood-brain barrier is not available.

Metabolism Dantrolene is found in measurable amounts in blood and urine. Its major metabolites in body fluids are 5-hydroxy dantrolene and an acetylamino metabolite of dantrolene. Another metabolite with an unknown structure appears related to the latter.

Dantrolene may also undergo hydrolysis and subsequent oxidation forming nitrophenylfuroic acid. Following RYANODEX 2.5 mg/kg dose administration in healthy volunteers, mean peak plasma concentration for the primary metabolite, 5-hydroxydantrolene, was 640 ng/mL, and was achieved by approximately 24 hours post-dose, with an average metabolite-to-parent exposure ratio of 0.27 (AUC 0-inf = 21.2 μg*h/mL). Median t 1/2 for 5-hydroxydantrolene was 10 hours, the clearance was estimated to be

8.9L/hr and the terminal phase volume of distribution was 144 L. Dantrolene is metabolized by the liver, and it is possible that its metabolism may be enhanced by drugs known to induce hepatic microsomal enzymes. However, neither phenobarbital nor diazepam appears to affect dantrolene metabolism.

🧬 Pharmacodynamics 36 words ▾

12.2Pharmacodynamics The administration of intravenous dantrolene to human volunteers was associated with loss of grip strength and weakness in the legs, as well as subjective CNS complaints [see Warnings and Precautions ( 5.1 )] .

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis 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 (approximately the same as the maximum recommended daily human dose on a mg/m 2 basis), there was an increase in the incidence of benign hepatic lymphatic neoplasms. In a 30-month study in Sprague-Dawley rats fed dantrolene sodium, the highest dose level (approximately the same as the maximum recommended daily human dose on a mg/m 2 basis) 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.

The significance of carcinogenicity data relative to use of RYANODEX in humans is unknown. Mutagenesis Dantrolene sodium has produced positive results in the Ames S. Typhimurium bacterial mutagenesis assay in the presence and absence of a liver activating system.

Impairment of Fertility Dantrolene sodium administered to male and female rats at dose levels up to 45 mg/kg/day (approximately 1.4 times the maximum recommended daily human dose on a mg/m 2 basis) showed no adverse effects on fertility or general reproductive performance.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis 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 (approximately the same as the maximum recommended daily human dose on a mg/m 2 basis), there was an increase in the incidence of benign hepatic lymphatic neoplasms. In a 30-month study in Sprague-Dawley rats fed dantrolene sodium, the highest dose level (approximately the same as the maximum recommended daily human dose on a mg/m 2 basis) 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.

The significance of carcinogenicity data relative to use of RYANODEX in humans is unknown. Mutagenesis Dantrolene sodium has produced positive results in the Ames S. Typhimurium bacterial mutagenesis assay in the presence and absence of a liver activating system.

Impairment of Fertility Dantrolene sodium administered to male and female rats at dose levels up to 45 mg/kg/day (approximately 1.4 times the maximum recommended daily human dose on a mg/m 2 basis) showed no adverse effects on fertility or general reproductive performance.

📄 Package Label / Principal Display Panel 130 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 42367-540-32 - Carton Label NDC 42367-540-32 Sterile Single Use Only - Discard Unused Portion Rx only Ryanodex ® (dantrolene sodium) for injectable suspension 250 mg per vial Reconstitution yields 50 mg/mL For treatment of malignant hyperthermia, along with the appropriate supportive measures. For intravenous use only Reconstitute with Sterile Water for Injection, USP SEE PACKAGE INSERT FOR COMPLETE PREPARATION INSTRUCTIONS AND PRESCRIBING INFORMATION. Carton Label

PRINCIPAL DISPLAY PANEL - NDC: 42367-540-32 - Vial Label NDC 42367-540-32 Sterile Single Use Only - Discard Unused Portion Rx only Ryanodex ® (dantrolene sodium) for injectable suspension 250 mg per vial Reconstitution yields 50 mg/mL For treatment of malignant hyperthermia, along with the appropriate supportive measures. For Intravenous Use Only Reconstitute with Sterile Water for Injection, USP Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dantrolene Sodium (matched by generic name) — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dantrolene Sodium. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$867.8K
Claims incl. refills
10.9K
Beneficiaries
4.5K
Spend / beneficiary
$190.81
Spend / claim
$79.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for RYANODEX dantrolene sodium (this brand).

Top reported reactions

Neuroleptic Malignant Syndrome44
Respiratory Failure35
Muscular Weakness29
Asthenia28
Pyrexia28
Convulsion26
Diarrhoea25

Age at onset

Child2
Adolescent2
Adult11
Elderly4

Reporter sex

409 reports
Male · 52%
Female · 48%
Unknown · 0%

Serious outcomes

Hospitalization180
Life-threatening44
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 18 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eagle Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eagle Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 42367-0531-33 · Eagle 42385-0030-01 · LAURUS →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.