FDA label
What is midazolam used for?
The FDA-approved uses of midazolam, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Midazolam injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerati...”
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Midazolam Hydrochloride, injection, solution
Indications and Usage, quoted from the label by Hospira, Inc. (ANDA075857). Cross-references to other label sections are left out.
Midazolam injection is indicated:
- intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
- intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
- intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
- continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
Source: DailyMed label, set id 1abda8b8-48a8-4995-af86-39220d1aa240, version 35, effective August 12, 2026. NDC 0409-0001, one of 43 listings for this product.
Midazolam Hydrochloride, syrup
Indications and Usage, quoted from the label by Precision Dose Inc. (ANDA075873). Cross-references to other label sections are left out.
Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use.
Source: DailyMed label, set id 557ef7bf-9341-47f9-804d-430a24982fa6, version 6, effective August 6, 2025. NDC 68094-762, one of 6 listings for this product.
Questions
What is midazolam used for?
The FDA label says: “Midazolam injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerati...”
What drug class is midazolam?
FDA lists midazolam in the Benzodiazepine established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Midazolam
- Is Midazolam a controlled substance?Schedule IV
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- Is Nayzilam a controlled substance?Schedule IV
- Benzodiazepines listFDA drug class
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- Schedule IV drugs listDEA schedule