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3/27/2023

Midazolam Injection

Products Affected - Description

    • Midazolam injection, Akorn, 5 mg/mL, 10 mL vial, 10 count, NDC 17478-0524-10 - discontinued
    • Midazolam injection, Fresenius Kabi, 5 mg/mL, 1 mL prefilled syringe, 24 count, NDC 76045-0002-10
    • Midazolam injection, Fresenius Kabi, 5 mg/mL, 10 mL vial, 10 count, NDC 63323-0412-10
    • Midazolam injection, Hikma, 5 mg/mL, 1 mL vial, 25 count, NDC 00641-6061-25
    • Midazolam injection, Hikma, 5 mg/mL, 2 mL vial, 25 count, NDC 00641-6063-25
    • Midazolam injection, Pfizer, 1 mg/mL, 10 mL vial, 10 count, NDC 00409-2587-05
    • Midazolam injection, Pfizer, 1 mg/mL, 2 mL preservative-free vial, 25 count, NDC 00409-2305-17
    • Midazolam injection, Pfizer, 5 mg/mL, 1 mL preservative-free vial, 10 count, NDC 00409-2308-01
    • Midazolam injection, Pfizer, 5 mg/mL, 2 mL preservative-free vial, 10 count, NDC 00409-2308-02

Reason for the Shortage

    • Akorn ceased operations in February 2023.
    • Athenex has midazolam injection available.
    • Avet has midazolam injection available.
    • Fresenius Kabi had midazolam injection on shortage due to increased demand. They are not marketing the 5 mg/mL 5 mL vials and 5 mg/mL 2 mL syringes.
    • Hikma did not provide a reason for the shortage.
    • Pfizer has midazolam injection on shortage due to manufacturing delays and increased demand.

Available Products

    • Midazolam injection, Athenex, 1 mg/mL, 2 mL vial, 25 count, NDC 70860-0600-02
    • Midazolam injection, Athenex, 5 mg/mL, 10 mL vial, 10 count, NDC 70860-0601-10
    • Midazolam injection, Avet Pharmaceuticals, 1 mg/mL, 2 mL vial, 25 count, NDC 23155-0600-41
    • Midazolam injection, Avet Pharmaceuticals, 5 mg/mL, 10 mL vial, 10 count, NDC 23155-0601-42
    • Midazolam injection, Avet Pharmaceuticals, 5 mg/mL, 5 mL vial, 10 count, NDC 23155-0601-41
    • Midazolam injection, Fresenius Kabi, 1 mg/mL, 10 mL vial, 10 count, NDC 63323-0411-10
    • Midazolam injection, Fresenius Kabi, 1 mg/mL, 2 mL prefilled syringe, 24 count, NDC 76045-0001-20
    • Midazolam injection, Fresenius Kabi, 1 mg/mL, 2 mL vial, 25 count, NDC 63323-0411-12
    • Midazolam injection, Fresenius Kabi, 1 mg/mL, 5 mL vial, 25 count, NDC 63323-0411-25
    • Midazolam injection, Fresenius Kabi, 5 mg/mL, 1 mL fill in 2 mL vial, 25 count, NDC 63323-0412-25
    • Midazolam injection, Fresenius Kabi, 5 mg/mL, 2 mL vial, 25 count, NDC 63323-0412-02
    • Midazolam injection, Hikma, 1 mg/mL, 10 mL vial, 10 count, NDC 00641-6056-10
    • Midazolam injection, Hikma, 1 mg/mL, 2 mL vial, 25 count, NDC 00641-6057-25
    • Midazolam injection, Hikma, 1 mg/mL, 5 mL vial, 10 count, NDC 00641-6059-10
    • Midazolam injection, Hikma, 5 mg/mL, 10 mL vial, 10 count, NDC 00641-6060-10
    • Midazolam injection, Pfizer, 1 mg/mL, 5 mL preservative-free vial, 10 count, NDC 00409-2305-05
    • Midazolam injection, Pfizer, 5 mg/mL, 10 mL vial, 10 count, NDC 00409-2596-05
    • Midazolam injection, Pfizer, 5 mg/mL, 5 mL vial, 10 count, NDC 00409-2596-03
    • Midazolam injection, WG Critical Care, 1 mg/mL, 100 mL premixed bag, 10 count, NDC 44567-0611-10
    • Midazolam injection, WG Critical Care, 1 mg/mL, 50 mL premixed bag, 10 count, NDC 44567-0610-10

Estimated Resupply Dates

    • Fresenius Kabi has short-dated midazolam 5 mg/mL 1 mL syringes available with an expiration date of < 3 months.
    • Hikma has midazolam 5 mg/mL 1 mL vials on back order and the company cannot estimate a release date. The 5 mg/mL 2 mL vials are on back order and the company estimates a release date of early-April 2023.
    • Pfizer has midazolam 1 mg/mL 2 mL preservative-free vials available in limited supply. The 1 mg/mL 10 mL vials are available in limited supply. The 5 mg/mL 2 mL preservative-free vials are available in limited supply. The 5 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of April 2023.

Updated

Updated March 27, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 25, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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