Quick answers
- What is Midazolam used for?
- The FDA-approved label (N/A, Rafa Laboratories, Ltd., February 18, 2026) says: “Midazolam Injection is indicated for the treatment of status epilepticus in adults. Midazolam Injection is a benzodiazepine indicated for the treatment of status epilepticus in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Midazolam have a boxed warning?
- Yes. The FDA label for N/A has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Midazolam?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 29, 2026). Ask your pharmacist about alternatives.
- Has Midazolam been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started October 27, 2017 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Midazolam?
- 24 companies list prescription products of Midazolam in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC and Onesource Specialty Pharma Limited.
What Midazolam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Midazolam Injection is indicated for the treatment of status epilepticus in adults. Midazolam Injection is a benzodiazepine indicated for the treatment of status epilepticus in adults.
— FDA label: N/A, Rafa Laboratories, Ltd., effective February 18, 2026. Read the full label on DailyMed →
The FDA has 44 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
44 of 44 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Syrup · Spray |
|---|---|
| Route | Intravenous · Intramuscular · Oral · Nasal |
| Prescription products | 74 in the FDA NDC Directory |
| Brand names | Nayzilam |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| midazolam 5 mg/0.1 mL spray | Brand: Nayzilam | $326.97 per unit |
| midazolam hydrochloride 1 mg/mL injection | Generic | $0.2305 per mL |
| midazolam hydrochloride 1 mg/mL injection, solution | Generic | $0.2305 per mL |
| midazolam hydrochloride 2 mg/mL syrup | Generic | $0.6221 per mL |
| midazolam hydrochloride 5 mg/mL injection | Generic | $0.3817–$0.5053 per mL 4 packages, lowest to highest |
| midazolam hydrochloride 5 mg/mL injection, solution | Generic | $0.3817–$1.22 per mL 6 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.17 products
- Fresenius Kabi USA, LLC7 products
- Onesource Specialty Pharma Limited7 products
- Hospira, Inc.7 products
- Henry Schein, Inc.5 products
- Gland Pharma Limited4 products
- Sagent Pharmaceuticals3 products
- Somerset Therapeutics, LLC3 products
- Civica, Inc.2 products
- Precision Dose, Inc.2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- A-S Medication Solutions2 products
- Micro Labs Limited2 products
- B. Braun Medical Inc.2 products
- WG Critical Care, LLC2 products
- American Health Packaging1 product
- Bryant Ranch Prepack1 product
- Remedyrepack Inc.1 product
- Padagis US LLC1 product
- Belcher Pharmaceuticals, LLC1 product
- Jvet Pharmaceuticals LLC1 product
- Cardinal Health 107, LLC1 product
- UCB, Inc.1 product
- Rafa Laboratories, Ltd.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211321 NAYZILAM | Ucb Inc | May 17, 2019 | 2, latest January 13, 2023 2023: Labeling · 2021: Labeling |
| NDA211844 MIDAZOLAM IN 0.9% SODIUM CHLORIDE | Inforlife | March 22, 2021 | 3, latest July 18, 2024 2024: Labeling · 2023: Labeling · 2021: Labeling |
| NDA216359 MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) | Rafa Labs Ltd | August 8, 2022 | 1, latest May 2, 2024 2024: Manufacturing (CMC) |
Generic approvals (16)
- ANDA075154Fresenius Kabi USA · June 20, 2000
- ANDA075243Hikma · June 20, 2000
- ANDA075293Hospira · June 20, 2000
- ANDA075873Hikma · April 30, 2002
- ANDA075857Hospira · July 22, 2002
- ANDA076379Padagis Us · May 2, 2005
- ANDA090315Onesource Specialty · November 29, 2010
- ANDA090316Onesource Specialty · May 4, 2011
- ANDA090850Gland Pharma Ltd · January 25, 2012
- ANDA090696Gland Pharma Ltd · February 29, 2012
- ANDA203460Fresenius Kabi USA · August 22, 2014
- ANDA212847Hikma · December 11, 2020
- ANDA216159Hikma · April 17, 2023
- ANDA217504Micro Labs · August 21, 2023
- ANDA218993Gland · August 12, 2024
- ANDA218454B Braun Medical · May 1, 2025
Shortage status
Current shortage · updated October 29, 2026 · first posted April 2, 2020
| Product | Midazolam Hydrochloride Preservative Free, Injection, 5 mg/mL (5 mg/mL) (NDC 0409-2308-01) |
|---|---|
| Availability | Unavailable |
| Reason given | Demand increase for the drug |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 27, 2017 · Class I · Terminated · D-0152-2018
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20 — Fresenius Kabi USA, LLC
-
December 16, 2016 · Class II · Terminated · D-0456-2017
Failed Impurities/Degradation Specifications
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05 — Fresenius Kabi USA, LLC
-
September 27, 2012 · Class II · Terminated · D-0295-2015
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25. — Fresenius Kabi USA, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — N/A, Rafa Laboratories, Ltd., effective February 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →