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Midazolam Injection (Nayzilam): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Controlled substance Schedule IV Boxed warning Current since November 3, 2026
Strength:
2 mg/2 mL, 5 mg/mL, 10 mg/2 mL
Brand names:
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Midazolam Injection

INSTRUCTIONS FOR USE

Figure 1: Outer Packaging and Prefilled Syringe

NOTES:

  • Do not introduce any other fluid into the syringe at any time.
  • Do not dilute for IV push.
  • Do not re-sterilize the syringe.
  • Do not use this product on a sterile field.
  • This product is for single dose only.
  1. 1. Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged.
  2. 2.

    Remove the syringe from the outer packaging. (See Figure 2)

    Figure 2

  3. 3. Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  4. 4.

    Twist off the syringe tip cap. Do not remove the label around the luer lock collar. (See Figure 3)

    Figure 3

  5. 5. Expel air bubble(s). Adjust the dose (if applicable).
  6. 6. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
  7. 7. Discard the used syringe into an appropriate receptacle.

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The brand names mentioned in this document are the trademarks of their respective owners.

U.S. Patent 9,731,082; 10,661,018

www.fresenius-kabi.com/us

451524E

Revised: February 2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 203460 · View the label on DailyMed

Revision date stated in the text: February 2023

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Midazolam Injection

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IVSchedule IV: low potential for abuse relative to Schedule III.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Benzodiazepine
Active ingredient Midazolam hydrochloride
Dosage form Injection, solution
Route Intramuscular, Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) FRESENIUS KABI USA
FDA approval ANDA 203460Abbreviated New Drug Application (ANDA) – generic drug Approved August 22, 2014
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 18 labelers list this drug on DailyMed
Drug shortage
  • Current since November 3, 2026
Packages (NDC)
Package
2 mg/2 mL – 2 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-211-00
2 mg/2 mL – 2 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-001-00
5 mg/mL – 1 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-002-00
10 mg/2 mL – 2 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-003-00

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.