Midazolam
Midazolam is a short-acting benzodiazepine used for sedation, anxiety relief and memory blocking around procedures and surgery, for anesthesia, for sedation in critical care, and (as a nasal spray) for seizure clusters.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 40 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Midazolam is a powerful, short-acting benzodiazepine that calms the brain by boosting GABA, its calming messenger, and one of the most widely used sedatives for surgery, procedures and intensive care, with a nasal spray (Nayzilam) for seizure clusters in epilepsy; it has been on the U.S. market since about 1996 and is available generically. A single dose is usually well tolerated; expect drowsiness and patchy memory for a few hours, and some people get nausea or vomiting. The boxed warning centers on slowed or stopped breathing, especially with opioids, alcohol or other sedatives, which is why injections are given only under continuous monitoring; Nayzilam also carries abuse and dependence warnings.
Clinical pearls
- Arrange a ride home, and avoid driving until drowsiness has passed, and for a full day after anesthesia and surgery.
- Tell the team if you take erythromycin, diltiazem, verapamil, ketoconazole or itraconazole, which can make midazolam’s sedation last longer.
- Nayzilam goes in one nostril; with no response after 10 minutes, a second spray may go in the other nostril.
- If you are breastfeeding, watch the baby for unusual sleepiness or poor feeding, since midazolam passes into breast milk.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Using midazolam with opioids can cause profound sleepiness, dangerously slow breathing, coma and death. This combination should be reserved for when other options are not adequate, using the lowest dose for the shortest time, with close monitoring.
Benzodiazepines such as Nayzilam also carry a risk of abuse, misuse and addiction, which can lead to overdose or death. Mixing with alcohol, other medicines or illicit drugs raises that risk.
Regular use can cause physical dependence. If Nayzilam is used more often than directed, stopping suddenly or cutting the dose quickly can cause life-threatening withdrawal reactions, so a gradual taper is advised.
Patient information guide A plain-language walkthrough of Midazolam, written from its FDA label.
What Midazolam is used for
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Midazolam is used for sedation, anesthesia and, in one nasal form, seizures. Uses depend on the product.
- Midazolam injection (intramuscular or intravenous): sedation, anxiety relief and amnesia before surgery.
- Midazolam injection (intravenous): sedation during diagnostic, therapeutic or endoscopic procedures.
- Midazolam injection (intravenous): starting general anesthesia before other anesthetic agents.
- Midazolam injection (continuous infusion): sedation of intubated, mechanically ventilated patients in critical care.
- Midazolam in sodium chloride injection: continuous infusion sedation of intubated, ventilated adults, children and newborns.
- Midazolam hydrochloride oral syrup: pre-procedure sedation, anxiety relief and amnesia in children.
- Nayzilam nasal spray: seizure clusters in people 12 and older with epilepsy.
How Midazolam works
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Midazolam is a short-acting benzodiazepine that depresses the central nervous system. It is thought to enhance GABA, the brain's main calming signal, by binding to the benzodiazepine site on the GABA A receptor. The exact mechanism is not fully understood.
Midazolam dosage
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Dosing is individualized and depends on the product and route.
- Injections are given slowly by trained staff with monitoring.
- The oral syrup is a single pre-procedure dose in children in monitored settings.
- Nayzilam is a nasal spray used only for seizure clusters, with limits on doses and how often it can be used.
Dosing details from the FDA-approved label
From the Midazolam prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Preoperative sedation/anxiolysis/amnesia, intramuscular: good risk (ASA Physical Status I & II) adults below the age of 60 years
- 0.07 to 0.08 mg/kg IM (approximately 5 mg IM) administered up to 1 hour before surgery
- Injected deep in a large muscle mass; onset within 15 minutes, peaking at 30 to 60 minutes
- Preoperative sedation, intramuscular: patients 60 years or older (no concomitant narcotics)
- 2 to 3 mg (0.02 to 0.05 mg/kg) of midazolam produced adequate sedation in a study
- 1 mg IM may suffice for some older patients if the anticipated intensity and duration of sedation is less critical
- Dose must be individualized and reduced for patients with COPD, other higher risk surgical patients, patients 60 or more years of age, and those who received concomitant narcotics or other CNS depressants
- Intravenous sedation/anxiolysis/amnesia for procedures: healthy adults below the age of 60
- Titrate slowly to the desired effect (e.g., the initiation of slurred speech)
- Some patients may respond to as little as 1 mg
- Give over a period of at least 2 minutes and wait an additional 2 or more minutes to fully evaluate the sedative effect
- Maximum: No more than 2.5 mg should be given over a period of at least 2 minutes
- Narcotic premedication reduces the midazolam dosage required; 1 mg/mL formulation recommended
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS, Pediatric Use ). Midazolam injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam hydrochloride to be 3 to 4 times as potent per mg as diazepam. BECAUSE SERIOUS AND LIFE-THREATENING CARDIORESPIRATORY ADVERSE EVENTS HAVE BEEN REPORTED, PROVISION FOR MONITORING, DETECTION AND CORRECTION OF THESE REACTIONS MUST BE MADE FOR EVERY PATIENT TO WHOM MIDAZOLAM INJECTION IS ADMINISTERED, REGARDLESS OF AGE OR HEALTH STATUS. Excessive single doses or rapid intravenous administration may result in respiratory depression, airway obstruction and/or arrest. The potential for these latter effects is increased in debilitated patients, those receiving concomitant medications capable of depressing the CNS, and patients without an endotracheal tube but undergoing a procedure involving the upper airway such as endoscopy or dental (see Boxed WARNING and WARNINGS ). Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported in adult and pediatric patients. Should such reactions occur, caution should be exercised before continuing administration of midazolam hydrochloride (see WARNINGS ). Midazolam injection should only be administered IM or IV (see WARNINGS ). Care should be taken to avoid intra-arterial injection or extravasation (see WARNINGS ). Midazolam injection may be mixed in the same syringe with the following frequently used premedications: morphine sulfate, meperidine, atropine sulfate or scopolamine. Midazolam, at a concentration of 0.5 mg per mL, is compatible with 5% dextrose in water and 0.9% sodium chloride for up to 24 hours and with Lactated Ringer's solution for up to 4 hours. The 5 mg per mL formulation of midazolam may be diluted with 0.9% sodium chloride or 5% dextrose in water. Monitoring Patient response to sedative agents, and resultant respiratory status, is variable. Regardless of the intended level of sedation or route of administration, sedation is a continuum; a patient may move easily from light to deep sedation, with potential loss of protective reflexes. This is especially true in pediatric patients.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Midazolam side effects
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Common effects reported include:
Common side effects
- Vomiting
- Nausea
- Drowsiness
- Memory loss (impaired recall) for several hours
- Slight drop in blood pressure
- Slight rise in heart rate
- Breathing problems such as low oxygen, coughing or laryngospasm (with oral syrup in children)
- Drowsiness and memory impairment
When to get medical help
- Slow, shallow or stopped breathing, or trouble keeping the airway open
- Extreme sleepiness or being unable to wake, especially if combined with opioids or alcohol
- Low blood pressure needing treatment
- New or worsening depression, suicidal thoughts or unusual mood or behavior changes (antiepileptic drug warning, Nayzilam)
- Agitation, involuntary movements, hyperactivity or combativeness
- Signs of withdrawal such as seizures after stopping suddenly if used more often than directed
- Signs of abuse, misuse or addiction
Midazolam warnings and precautions
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- Breathing and heart risks: respiratory depression, airway obstruction, apnea and cardiac arrest have occurred, sometimes fatally.
- Opioids and other sedatives: greatly raise the risk of profound sedation and death.
- Abuse, dependence and withdrawal: a risk with benzodiazepines, including Nayzilam.
- Memory and alertness: avoid driving or hazardous machinery until effects have worn off.
- Suicidal thoughts: antiepileptic drugs, including Nayzilam, can raise this risk.
- Young children: prolonged anesthetic exposure raises concerns about brain development.
Midazolam interactions
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Several drugs can make midazolam stronger or last longer.
- Opioids: dangerous slowed breathing and sedation.
- Alcohol, barbiturates and other CNS depressants: added sedation and breathing risk.
- CYP3A4 inhibitors (erythromycin, diltiazem, verapamil, ketoconazole, itraconazole, cimetidine, saquinavir): slower clearance and prolonged sedation.
- Fentanyl in newborns: severe low blood pressure.
- Flumazenil: may trigger withdrawal and seizures.
Interactions listed in the FDA-approved label
From the Midazolam prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Opioids (benzodiazepines and opioids): Concomitant use increases the risk of respiratory depression; benzodiazepines can significantly worsen opioid-related respiratory depression. Monitor patients closely for respiratory depression and sedation.
- Other CNS depressants (opioids such as morphine, meperidine and fentanyl; secobarbital; droperidol): The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication which depresses the central nervous system. Adjust the midazolam dosage according to the type and amount of concomitant medications administered and the desired clinical response.
- P450 3A4 inhibitors (cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, itraconazole): May result in prolonged sedation due to a decrease in plasma clearance of midazolam. Caution is advised when given concomitantly.
- Ranitidine: Increased mean steady-state concentration of oral midazolam to 62 ng/mL; no change in choice reaction time or sedation index was detected.
- Saquinavir: A 56% reduction in the clearance of midazolam following a single 0.05 mg/kg IV dose was observed; the half-life was approximately doubled.
- Nifedipine: No interaction was observed in healthy subjects between midazolam and nifedipine.
- Thiopental: A moderate reduction in induction dosage requirements of thiopental (about 15%) has been noted following intramuscular midazolam premedication in adults.
- Halothane: Intravenous midazolam decreases the minimum alveolar concentration (MAC) of halothane required for general anesthesia, correlating with the midazolam dose.
- Fentanyl in neonates: Severe hypotension has been reported in neonates with concomitant administration of fentanyl and midazolam, with rapid injection of either drug while on an infusion of the other.
Read the label’s full interactions text
Drug Interactions For information concerning pharmacokinetic drug interactions with midazolam (see PRECAUTIONS ).
Drug Interactions Effect of Concomitant Use of Benzodiazepines and Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Monitor patients closely for respiratory depression and sedation. Other CNS Depressants The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication which depresses the central nervous system, particularly opioids (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. Consequently, the dosage of midazolam should be adjusted according to the type and amount of concomitant medications administered and the desired clinical response (see DOSAGE AND ADMINISTRATION ). Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. These drug interactions may result in prolonged sedation due to a decrease in plasma clearance of midazolam. The effect of single oral doses of 800 mg cimetidine and 300 mg ranitidine on steady-state concentrations of oral midazolam was examined in a randomized crossover study (n=8). Cimetidine increased the mean midazolam steady-state concentration from 57 to 71 ng/mL. Ranitidine increased the mean steady-state concentration to 62 ng/mL. No change in choice reaction time or sedation index was detected after dosing with the H2 receptor antagonists.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Midazolam
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- Do not use if allergic to midazolam or with acute narrow-angle glaucoma.
- Injectable forms with benzyl alcohol are contraindicated in premature infants.
- Use caution with COPD, kidney failure, heart failure, shock, coma or acute alcohol intoxication.
- Older adults and debilitated patients need lower doses.
- Late pregnancy use can cause newborn sedation or withdrawal.
- It passes into breast milk, so monitor infants for sedation and poor feeding.
- Nayzilam is not established for children under 12.
Midazolam overdose
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Too much can cause drowsiness, confusion, poor coordination and weak muscle tone, and in severe cases slowed breathing and coma. It can be fatal with alcohol or opioids. Treatment is supportive care such as fluids and airway support, and flumazenil may be used with caution because it can cause withdrawal and seizures. Contact a poison center at 1-800-222-1222.
What Midazolam does in the body
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Effects depend on the dose, route and other medicines. After an injection into a muscle, sedation starts in about 15 minutes in adults and within 5 minutes in children. After an IV injection, sedation occurs within 3 to 5 minutes. Midazolam commonly blocks memory of the procedure and can reduce the breathing response to carbon dioxide, particularly in people with COPD.
How your body processes Midazolam
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Midazolam is rapidly absorbed when taken by mouth, but much of it is broken down in the gut and liver on first pass. People with kidney failure or heart failure clear it more slowly. Drugs that block CYP3A4 can slow its clearance and lengthen its effects.
How to store Midazolam
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Store at 20° to 25°C (68° to 77°F). Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Midazolam
202 supplements and herbal products have documented interactions with Midazolam in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 153
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Midazolam: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Midazolam — the kind of thing our pharmacy team would talk through with you at the counter.
What is midazolam used for?
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How is it given?
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What side effects should I expect?
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Can I drink alcohol or take opioids with it?
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Can I drive afterward?
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Is it safe in pregnancy?
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Is Midazolam available over the counter?
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Is Midazolam a controlled substance?
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When was Midazolam first available?
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Who makes Midazolam?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Midazolam on HelloPharmacist
Midazolam forms and strengths (how it comes)
Midazolam is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Midazolam inactive ingredients by manufacturer.
Injection
How this form is used
- Midazolam injection is used for sedation, anxiety relief and amnesia before or during procedures and surgery.
- Midazolam injection is also used to induce general anesthesia.
- Midazolam in sodium chloride injection is used for continuous infusion sedation of intubated, ventilated adults, children and newborns.
- Midazolam injection requires slow administration and individualized dosing, with monitoring for breathing and heart problems.
- Midazolam in sodium chloride injection is for intravenous use only, and trained personnel should give it.
- Midazolam injection should only be given into a muscle or vein, avoiding injection into an artery.
Oral solution
How this form is used
- Midazolam hydrochloride syrup is used in children for sedation, anxiety relief and amnesia before procedures or anesthesia.
- Midazolam hydrochloride syrup is given as a single dose before a procedure, not for chronic or home use.
- Midazolam hydrochloride syrup should be used only where breathing and heart function can be continuously monitored.
Nasal spray
How this form is used
- Nayzilam treats seizure clusters in people 12 and older with epilepsy.
- Nayzilam is sprayed into the nose only, one spray in one nostril.
- A second spray in the opposite nostril may be used after 10 minutes if there is no response.
- Nayzilam should not be used for more than 2 doses per episode, one episode every three days, or more than five episodes per month.
Midazolam on the U.S. market: products, makers and brands
How Midazolam appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
24 companies list 76 Midazolam product records with the FDA, mostly as injection, oral solution, nasal spray; the earliest marketing or approval year on record is 1985. Brand names on the directory include Versed, Nayzilam, Midazolam in Sodium Chloride and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Midazolam is used (Medicaid data)
A general measure of how commonly Midazolam is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Midazolam is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Midazolam prescribed? Of the 1,601 medications we measure, Midazolam ranks #290 by Medicaid prescriptions — more than 82% of them.
Utilization by Midazolam product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
midazolam 1 MG/ML Injectable Solution Most dispensed
Summed across the 10 of 42 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311700
2 ML midazolam 1 MG/ML Injection
Summed across the 7 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666798
midazolam 50 MG/ML Nasal Spray
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2173494
5 ML midazolam 1 MG/ML Injection
Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666800
midazolam 5 MG/ML Injectable Solution
Summed across the 12 of 68 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311702
2 ML midazolam 5 MG/ML Injection
Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666823
midazolam 2 MG/ML Oral Solution
Summed across the 6 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 422410
1 ML midazolam 5 MG/ML Injection
Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666814
2 ML midazolam 1 MG/ML Prefilled Syringe
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998211
1 ML midazolam 5 MG/ML Prefilled Syringe
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1551395
100 ML midazolam 1 MG/ML Injection
Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2541171
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Midazolam, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 47 of 213 listed Midazolam NDCs with Medicaid activity.
Compare Midazolam products
A representative set of FDA-listed product records for Midazolam — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1 mg/mL | Intramuscular, Intravenous | A-S Medication Solutions | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | A-S Medication Solutions | ANDA | View NDC → |
| 1 mg/mL | Intravenous | B. Braun Medical Inc. × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Belcher Pharmaceuticals, LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Cardinal Health 107, LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Civica, Inc. × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Fresenius Kabi Usa, Llc | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 2 mg/2 mL | Intramuscular, Intravenous | Fresenius Kabi USA, LLC × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Fresenius Kabi USA, LLC × 2 listings | ANDA | View NDC → |
| 10 mg/2 mL | Intramuscular, Intravenous | Fresenius Kabi USA, LLC | ANDA | View label ↗ |
| 1 mg/mL | Intramuscular, Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Gland Pharma Limited × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Henry Schein, Inc. × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Henry Schein, Inc. × 3 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. × 7 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. × 7 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Hospira, Inc. × 3 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Hospira, Inc. × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Jvet Pharmaceuticals LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Micro Labs Limited | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Micro Labs Limited | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Onesource Specialty Pharma Limited × 3 listings | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Onesource Specialty Pharma Limited × 4 listings | ANDA | View NDC → |
| 2 mg/2 mL | Intramuscular, Intravenous | Remedyrepack Inc. | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 2 mg/2 mL | Intramuscular, Intravenous | Somerset Therapeutics, Llc | ANDA | View NDC → |
| 5 mg/5 mL | Intramuscular, Intravenous | Somerset Therapeutics, Llc | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Somerset Therapeutics, Llc | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous | Steriscience Specialties Private Limited | ANDA | View NDC → |
| 5 mg/mL | Intramuscular, Intravenous | Steriscience Specialties Private Limited × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Intravenous | WG Critical Care, LLC. × 2 listings | NDA | View NDC → |
| 💊Nasal spray | ||||
| 5 mg/0.1 mL | Nasal | UCB, Inc. | NDA | View NDC → |
| 💊Oral solution | ||||
| 2 mg/mL | Oral | American Health Packaging | ANDA | View NDC → |
| 2 mg/mL | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 2 mg/mL | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 2 mg/mL | Oral | Padagis US LLC | ANDA | View NDC → |
| 2 mg/mL | Oral | Precision Dose Inc. × 2 listings | ANDA | View NDC → |
Showing 76 of 76 products — FDA National Drug Code Directory. See every product, package size and price: browse all 76 Midazolam NDCs →
Midazolam side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Midazolam — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Midazolam are seizure, hypotension, drug interaction; about 93% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Midazolam in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Midazolam FDA approval history
How Midazolam went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Midazolam was first approved by the FDA in 1985 (Brand: VERSED · Hlr); the first generic version was approved in 2000. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Midazolam recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Midazolam recalls since July 2021.
✅No Midazolam recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 6960 8 dose forms · 18 strengths
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Dose form (SCDF) Auto-Injector RxCUI 2608697In current FDA listingsClinical drug / strength (SCD) 0.7 ML midazolam 14.3 MG/MLRxCUI 2608698 -
Dose form (SCDF) Cartridge RxCUI 1666776No current FDA listingClinical drug / strength (SCD) 1 ML midazolam 5 MG/MLRxCUI 16668212 ML midazolam 1 MG/MLRxCUI 1666777 -
Dose form (SCDF) Injectable Solution RxCUI 379133In current FDA listings -
Dose form (SCDF) Injection RxCUI 1666797In current FDA listingsClinical drug / strength (SCD) 1 ML midazolam 5 MG/MLRxCUI 16668142 ML midazolam 1 MG/MLRxCUI 16667982 ML midazolam 5 MG/MLRxCUI 16668235 ML midazolam 1 MG/MLRxCUI 166680050 ML midazolam 1 MG/MLRxCUI 2541170100 ML midazolam 1 MG/MLRxCUI 2541171 -
Dose form (SCDF) Nasal Spray RxCUI 2173493In current FDA listingsClinical drug / strength (SCD) 50 MG/MLRxCUI 2173494 -
Dose form (SCDF) Oral Solution RxCUI 446503In current FDA listingsClinical drug / strength (SCD) 2 MG/MLRxCUI 422410 -
Dose form (SCDF) Oral Tablet RxCUI 372922No current FDA listingClinical drug / strength (SCD) 15 MGRxCUI 248630 -
Dose form (SCDF) Prefilled Syringe RxCUI 998210No current FDA listingClinical drug / strength (SCD) 1 ML midazolam 5 MG/MLRxCUI 15513952 ML midazolam 1 MG/MLRxCUI 9982112 ML midazolam 5 MG/MLRxCUI 1551393
Look up RxCUI 6960 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Midazolam supply and shortage status
Whether Midazolam is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Midazolam is currently listed in shortage by the FDA (10 presentations on record).
⚠️Currently in shortage (FDA) — MidazolamRead the full Midazolam shortage page — affected NDCs, other makers, and what to do →
Source: openFDA, from the FDA Drug Shortages database.
💵 What Midazolam costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Injection, Solution · Intramuscular, Intravenous | 1 mg/mL | $0.420 per mL | NDC details & price history |
| Injection, Solution · Intramuscular; Intravenous | 1 mg/mL | $0.420 per mL | NDC details & price history |
| Injection · Intramuscular; Intravenous | 5 mg/mL | $0.382 per mL | NDC details & price history |
| Syrup · Oral | 2 mg/mL | $0.618 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Midazolam brand names
Midazolam is sold under 4 brand names in the FDA directory — Versed, Nayzilam, Midazolam in Sodium Chloride, Midazolam In 0.8% Sodium Chloride. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Midazolam: manufacturers and labelers
24 companies list Midazolam products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC, Onesource Specialty Pharma Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Midazolam drug class (RxNorm)
Midazolam belongs to the Benzodiazepine class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Midazolam page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →