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Methohexital Sodium 500 mg/500mg Injection — NDC 23155-893-31 (Billing 23155-0893-31)

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 1 VIAL in 1 CARTON / 500 mg in 1 VIAL

This is a package of Methohexital Sodium 500 mg/500mg Injection from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., marketed since Dec 2024 and currently FDA-listed. It is this product's only package size.

NDC 23155-0893-31
🏷️ FDA NDC (as labeled) 23155-893-31 billing pads the product segment with a zero
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🚨
Active recall for this product.
Class II · Jun 7, 2026 — Failed Impurities/Degradation Specifications (ONESOURCE SPECIALTY PHARMA LIMITED) · FDA recall D-0662-2026
Lots / codes: Lot #: 7000612A, Exp. Date 1/2028 · reported Jul 15, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 23155-893-31
Product NDC 23155-893
11-digit billing NDC 23155089331
NCPDP billing unit EA — each (per item)
RxCUI 1244233
UNII 60200PNZ7Q
UPC 0323155893311, 0011100004492
Application # ANDA215488
SPL Set ID f76d4ab9-2f6c-420b-afec-b9cdfdc083ce
Established class (EPC) Barbiturate
Chemical class Barbiturates
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-12
Route INTRAMUSCULAR, INTRAVENOUS, RECTAL
Dosage form INJECTION
Substance METHOHEXITAL SODIUM
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 003561
GCN 12801
HICL code 001552
Ingredient (HICL) Methohexital Sodium
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2C
Therapeutic class — specific (HIC3) General Anesthetics,Injectable
AHFS code 28:04.04.00
AHFS class Barbiturates (General Anesthetics)
FDB label name METHOHEXITAL SODIUM 500MG VIAL
FDB brand name Methohexital Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003561
  • GCN: 12801
  • HICL (First Databank): 001552
  • AHFS class code: 28:04.04.00
  • RxCUI (RxNorm): 1244233
Why two NDCs? The FDA registers this code as 23155-893-31 — 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 → 23155-0893-31. 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 Barbiturate class.

Pharmacologic class Barbiturate
Drug family (ATC) Barbiturates, plain, Barbiturates, plain
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 METHOHEXITAL SODIUM 500MG VIAL Ingredient Methohexital Sodium
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 eachPer 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
23155-0893-31 You're viewing this Main listing 1 VIAL in 1 CARTON / 500 mg in 1 VIAL 2024-12-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methohexital Sodium 500 mg/500mgthis 23155-0893-31 Heritage 1 vial — AP FDA listed —
Brevital Sodium 500 mg 42023-0105-01 Par 1 vial — AP FDA listed —
Methohexital Sodium 500 mg/500mg 83270-0003-01 ONESOURCE 500 mg — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application holderONESOURCE SPECIALTY PTE LTD
FDA applicationANDA215488 (ANDA)
Labeler code23155
First marketedDec 2024
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio253 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.
🚨 Boxed Warning 82 words ▾

WARNING Methohexital Sodium for Injection should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient.

(See WARNINGS .)

🎯 Indications and Usage 185 words ▾

INDICATIONS AND USAGE Methohexital Sodium for Injection can be used in adults as follows: For intravenous induction of anesthesia prior to the use of other general anesthetic agents. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; Methohexital Sodium for Injection may be given by infusion or intermittent injection. For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures.

As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (See WARNINGS ). As an agent for inducing a hypnotic state. Methohexital Sodium for Injection can be used in pediatric patients older than 1 month as follows: For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents.

For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures. As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Facilities for assisting ventilation and administering oxygen are necessary adjuncts for all routes of administration of anesthesia. Since cardiorespiratory arrest may occur, patients should be observed carefully during and after use of Methohexital sodium for injection. Age- and size- appropriate resuscitative equipment (i.e., intubation and cardioversion equipment, oxygen, suction, and a secure intravenous line) and personnel qualified in its use must be immediately available.

Preanesthetic medication is generally advisable. Methohexital Sodium for Injection may be used with any of the recognized preanesthetic medications. Preparation of Solution FOLLOW DILUTION INSTRUCTIONS EXACTLY.

Freshly prepare solutions of Methohexital Sodium for Injection and use promptly. Reconstituted solutions of Methohexital Sodium for Injection are chemically stable at room temperature for 24 hours. Diluents ONLY USE BACTERIOSTATIC-FREE DILUENT - Recommended diluents are based on route of administration (See dilution instructions ).

Incompatible diluents: Lactated Ringer's Injection Dilution Instructions 1% solutions (10 mg/mL) should be prepared for intermittent intravenous and rectal administration; 0.2% solutions (2 mg/mL) should be prepared for continuous intravenous drug administration; 5% solutions (50 mg/mL) should be prepared for intramuscular administration. Contents of vials should be diluted as follows: FOR INTERMITTENT INTRAVENOUS and RECTAL ADMINISTRATION The preferred diluent for intermittent intravenous and rectal administration is Sterile Water for Injection.

5% Dextrose Injection, or 0.9% Sodium Chloride Injection are also acceptable diluents. Strength Amount of Diluent to Be Added to the Contents of the Methohexital Sodium for Injection Vial For 1% methohexital solution (10 mg/mL) 500 mg 50 mL no further dilution needed FOR CONTINUOUS INTRAVENOUS ADMINISTRATION For continuous drip anesthesia, prepare a 0.2% solution by adding 500 mg of Methohexital Sodium for Injection to 250 mL of diluent. For this dilution, either 5% glucose solution or isotonic (0.9%) sodium chloride solution ONLY is recommended as the diluent instead of sterile water for injection in order to avoid extreme hypotonicity.

Strength Amount of Diluent to Be Added to the Contents of the Methohexital Sodium for Injection Vial For 0.2% methohexital solution (2 mg/mL) 500 mg 15 mL add to 235 mL diluent for 250 mL total volume FOR INTRAMUSCULAR ADMINISTRATION The preferred diluent for intramuscular administration is Sterile Water for Injection. 0.9% Sodium Chloride Injection is also an acceptable diluent. Strength Amount of Diluent to Be Added to the Contents of the Methohexital Sodium for Injection Vial For 5% methohexital solution (50 mg/mL) 500 mg 10 mL no further dilution needed Administration Dosage is highly individualized; the drug should be administered only by those completely familiar with its quantitative differences from other barbiturate anesthetics.

Adults Methohexital Sodium for Injection is administered intravenously in a concentration of no higher than 1 %. Higher concentrations markedly increase the incidence of muscular movements and irregularities in respiration and blood pressure. Induction of Anesthesia For induction of anesthesia, a 1% solution is administered at a rate of about 1 mL/5 seconds.

Gaseous anesthetics and/or skeletal muscle relaxants may be administered concomitantly. The dose required for induction may range from 50 to 120 mg or more but averages about 70 mg. The usual dosage in adults ranges from 1 to 1.5 mg/kg.

The induction dose usually provides anesthesia for 5 to 7 minutes Maintenance of anesthesia Maintenance of anesthesia may be accomplished by intermittent injections of the 1% solution or, more easily, by continuous intravenous drip of a 0.2% solution. Intermittent injections of about 20 to 40 mg (2 to 4 mL of a 1% solution) may be given as required, usually every 4 to 7 minutes. For continuous dri… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 31 words ▾

CONTRAINDICATIONS Methohexital Sodium for Injection is contraindicated in patients in whom general anesthesia is contraindicated, in those with latent or manifest porphyria, or in patients with a known hypersensitivity to barbiturates.

⚠️ Warnings ~3 min read ▾

WARNINGS As with all potent anesthetic agents and adjuncts, Methohexital Sodium for Injection should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient.

Maintenance of a patent airway and adequacy of ventilation must be ensured during induction and maintenance of anesthesia with methohexital sodium solution. Laryngospasm is common during induction with all barbiturates and may be due to a combination of secretions and accentuated reflexes following induction or may result from painful stimuli during light anesthesia. Apnea/hypoventilation may be noted during induction, which may impair pulmonary ventilation; the duration of apnea may be longer than that produced by other barbiturate anesthetics.

Cardiorespiratory arrest may occur. This prescribing information describes intravenous use of methohexital sodium in adults. It also discusses intramuscular and rectal administration in pediatric patients older than one month.

Although the published literature discusses intravenous administration in pediatric patients, the safety and effectiveness of intravenous administration of methohexital sodium in pediatric patients have not been established in well-controlled, prospective studies. (See PRECAUTIONS/Pediatric Use ). Seizures may be elicited in subjects with a previous history of convulsive activity, especially partial seizure disorders.

Because the liver is involved in demethylation and oxidation of methohexital and because barbiturates may enhance preexisting circulatory depression, severe hepatic dysfunction, severe cardiovascular instability, or a shock-like condition may be reason for selecting another induction agent. Prolonged administration may result in cumulative effects, including extended somnolence, protracted unconsciousness, and respiratory and cardiovascular depression. Respiratory depression in the presence of an impaired airway may lead to hypoxia, cardiac arrest, and death.

The CNS-depressant effect of Methohexital Sodium for Injection may be additive with that of other CNS depressants, including ethyl alcohol and propylene glycol. DANGER OF INTRA-ARTERIAL INJECTION-Unintended intra-arterial injection of barbiturate solutions may be followed by the production of platelet aggregates and thrombosis, starting in arterioles distal to the site of injection. The resulting necrosis may lead to gangrene, which may require amputation.

The first sign in conscious patients may be a complaint of fiery burning that roughly follows the distribution path of the injected artery; if noted, the injection should be stopped immediately and the situation reevaluated. Transient blanching may or may not be noted very early; blotchy cyanosis and dark discoloration may then be the first sign in anesthetized patients. There is no established treatment other than prevention.

The following should be considered prior to injection: The extent of injury is related to concentration. Concentrations of 1 % methohexital will usually suffice; higher concentrations should ordinarily be avoided. Check the infusion to ensure that the catheter is in the lumen of a vein before injection.

Injection through a running intravenous infusion may enhance the possibilty of detecting arterial placement; however, it should be remembered that the characteristic bright-red color of arterial blood is often altered by contact with drugs. The possibility of aberrant arteries should always be considered. Post injury arterial injection of vasodilators and/or arterial infusion of parenteral fluids are… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 137 words ▾

ADVERSE REACTIONS Side effects associated with Methohexital Sodium for Injection are extensions of pharmacologic effects and include: Cardiovascular Circulatory depression, thrombophlebitis, hypotension, tachycardia, peripheral vascular collapse, and convulsions in association with cardiorespiratory arrest Respiratory Respiratory depression (including apnea), cardiorespiratory arrest, laryngospasm, bronchospasm, hiccups, and dyspnea Neurologic Skeletal muscle hyperactivity (twitching), injury to nerves adjacent to injection site, and seizures Psychiatric Emergence delirium, restlessness, and anxiety may occur, especially in the presence of postoperative pain Gastrointestinal Nausea, emesis, abdominal pain, and liver function tests abnormal Allergic Erythema, pruritus, urticaria, and cases of anaphylaxis have been reported rarely Other Other adverse reactions include pain at injection site, salivation, headache, and rhinitis For medical advice about adverse reactions contact your medical professional.

To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or "http://www.fda.gov/medwatch".

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Signs and Symptoms The onset of toxicity following an overdose of intravenously administered methohexital will be within seconds of the infusion. If methohexital is administered rectally or is ingested, the onset of toxicity may be delayed. The manifestations of an ultrashort-acting barbiturate in overdose include central nervous system depression, respiratory depression, hypotension, loss of peripheral vascular resistance, and muscular hyperactivity ranging from twitching to convulsive-like movements.

Other findings may include convulsions and allergic reactions. Following massive exposure to any barbiturate, pulmonary edema, circulatory collapse with loss of peripheral vascular tone, and cardiac arrest may occur. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center.

Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibiity of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Establish an airway and ensure oxygenation and ventilation.

Resuscitative measures should be initiated promptly. For hypotension, intravenous fluids should be administered and the patient's legs raised. If desirable increase in blood pressure is not obtained, vasopressor and/or inotropic drugs may be used as dictated by the clinical situation.

For convulsions, diazepam intravenously and phenytoin may be required. If the seizures are refractory to diazepam and phenytoin, general anesthesia and paralysis with a neuromuscular blocking agent may be necessary. Protect the patient's airway and support ventilation and perfusion.

Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed.

Safeguard the patient's airway when employing gastric emptying or charcoal.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Compared with thiamylal and thiopental, methohexital is at least twice as potent on a weight basis, and its duration of action is only about half as long. Although the metabolic fate of methohexital in the body is not clear, the drug does not appear to concentrate in fat depots to the extent that other barbiturate anesthetics do. Thus, cumulative effects are fewer and recovery is more rapid with methohexital than with thiobarbiturates.

In experimental animals, the drug cannot be detected in the blood 24 hours after administration. Methohexital differs chemically from the established barbiturate anesthetics in that it contains no sulfur. Little analgesia is conferred by barbiturates; their use in the presence of pain may result in excitation.

Intravenous administration of methohexital results in rapid uptake by the brain (within 30 seconds) and rapid induction of sleep. Following intramuscular administration to pediatric patients, the onset of sleep occurs in 2 to 10 minutes. A plasma concentration of 3 mcg/mL was achieved in pediatric patients 15 minutes after an intramuscular dose (10 mg/kg) of a 5% solution.

Following rectal administration to pediatric patients, the onset of sleep occurs in 5 to 15 minutes. Plasma methohexital concentrations achieved following rectal administration tend to increase both with dose and with the use of more dilute solution concentrations when using the same dose. A 25 mg/kg dose of a 1% methohexital solution yielded plasma concentrations of 6.9 to 7.9 mcg/mL 15 minutes after dosing.

The absolute bioavailability of rectal methohexital sodium is 17%. With single doses, the rate of redistribution determines duration of pharmacologic effect. Metabolism occurs in the liver through demethylation and oxidation.

Side-chain oxidation is the most important biotransformation involved in termination of biologic activity. Excretion occurs via the kidneys through glomerular filtration.

📦 How Supplied / Storage and Handling 51 words ▾

HOW SUPPLIED Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Methohexital Sodium for Injection is a white, freeze-dried plug/lyophilized cake, filled in Vials*: The 500 mg vials (with 30 mg anhydrous sodium carbonate) are available as follows: • NDC 23155-893-31–Multi-Dose Vial–Pack of 1 *In crystalline form.

📋 Description 167 words ▾

DESCRIPTION Methohexital Sodium for injection, is 2,4,6 (1H, 3H, 5H)-Pyrimidinetrione, 1- methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt and has the empirical formula C 14 H 17 N 2 NaO 3 . Its molecular weight is 284.29. The structural formula is as follows: Methohexital sodium is a rapid, ultrashort-acting barbiturate anesthetic.

Methohexital sodium for injection is a freeze-dried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. It contains not less than 90% and not more than 110% of the labeled amount of methohexital sodium. It occurs as a white, freeze-dried plug that is freely soluble in water.

This product is oxygen sensitive. The pH of the 1% solution is between 10 and 11; the pH of the 0.2% solution in 5% dextrose is between 9.5 and 10.5. Methohexital sodium may be administered by direct intravenous injection or continuous intravenous drip, intramuscular or rectal routes (See PRECAUTIONS/Pediatric Use ).

Reconstituting instructions vary depending on the route of administration (See DOSAGE AND ADMINISTRATION ). structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General All routes of administration of Methohexital Sodium for Injection are often associated with hiccups, coughing, and/or muscle twitching, which may also impair pulmonary ventilation. Following induction, temporary hypotension and tachycardia may occur. Recovery from methohexital anesthesia is rapid and smooth.

The incidence of postoperative nausea and vomiting is low if the drug is administered to fasting patients. Postanesthetic shivering has occurred in a few instances. The usual precautions taken with any barbiturate anesthetic should be observed with Methohexital Sodium for Injection.

The drug should be used with caution in patients with asthma, obstructive pulmonary disease, severe hypertention or hypotension, myocardial disease, congestive heart failure, severe anemia, or extreme obesity. Methohexital sodium should be used with extreme caution in patients in status asthmaticus. Caution should be exercised in debilitated patients or in those with impaired function of respiratory, circulatory, renal, hepatic, or endocrine systems.

Information for Patients Risk of Drowsiness When appropriate, patients should be instructed as to the hazards of drowsiness that may follow use of Methohexital Sodium for Injection. Outpatients should be released in the company of another individual, and no skilled activities, such as operating machinery or driving a motor vehicle, should be engaged in for 8 to 12 hours. Effect of anesthetic and sedation drugs on early brain development Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains.

Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs (See WARNINGS/Pediatric Neurotoxicity ). Laboratory Tests BSP and liver function studies may be influenced by administration of a single dose of barbiturates. Drug Interactions Prior chronic administration of barbiturates or phenytoin (e.g. for seizure disorder) appears to reduce the effectiveness of Methohexital Sodium for Injection.

Barbiturates may influence the metabolism of other concomitantly used drugs, such as phenytoin, halothane, anticoagulants, corticosteroids, ethyl alcohol, and propylene glycol-containing solutions. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of methohexital have not been conducted. Mutagenesis Methohexital was negative in the in vitro bacterial reverse mutation assay (Ames test) using Salmonella typhimurium strains TA97, TA98, TA100, and TA1535.

Impairment of Fertility Reproduction studies in animals have revealed no evidence of impaired fertility. Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, no adverse developmental effects were observed following administration of methohexital to pregnant rabbits and rats during organogenesis at doses up to 4 and 7 times the human dose respectively.

Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [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. Data Animal Da… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 23 words ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance - Methohexital Sodium for Injection is a Schedule IV drug. Methohexital Sodium for lnjection may be habit-forming.

📄 Package Label / Principal Display Panel 85 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Vial ​NDC ​23155- ​893 ​-31 ​Rx only Methohexital Sodium for Injection, USP ​CIV 500 mg/Vial ANESTHETIC BARBITUATE Preservative Free - Discard Unused Portion After 24 hours 500 mg Multiple Dose Vial 500mg-vial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton ​NDC ​23155-893-31 ​Rx only ​ ​Methohexital Sodium for Injection, USP CIV 500 mg/Vial ANESTHETIC BARBITUATE Preservative Free - Discard Unused Portion After 24 hours Do not administer without reading directions in full prescribing information. 500 mg x 1 Multiple Dose Vial 500mg-carton

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

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 Methohexital Sodium — the ingredient across all brands.

Top reported reactions

Product Quality Issue25
Drug Effect Decreased7
Vomiting7
Nausea6
Drug Effect Less Than Expected5
Unwanted Awareness During Anaesthesia5
Hypotension4

Reporter sex

122 reports

Serious outcomes

Hospitalization12
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 15 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“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 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Heritage Pharmaceuticals Inc. d/b/a Avet 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.
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.