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4/9/2025

Midazolam Injection

Products Affected - Description

    • Midazolam injection, Hikma, 1 mg/mL, 10 mL vial, 10 count, NDC 00641-6056-10
    • Midazolam injection, Hikma, 1 mg/mL, 2 mL prefilled syringe, 10 count, NDC 00641-6220-10
    • 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, Hikma, 5 mg/mL, 2 mL prefilled syringe, 10 count, NDC 00641-6219-10
    • Midazolam injection, Pfizer, 1 mg/mL, 10 mL vial, 10 count, NDC 00409-2587-05
    • Midazolam injection, Sagent, 5 mg/mL, 10 mL vial, 10 count, NDC 25021-0661-10

Reason for the Shortage

    • Akorn ceased operations in February 2023.
    • Avet has midazolam injection available.
    • Fresenius Kabi has midazolam injection available.
    • Hikma did not provide a reason for the shortage.
    • Pfizer has midazolam injection available.
    • Sagent has midazolam injection on shortage due to increased demand.
    • Somerset has midazolam injection available.

Available Products

    • 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 prefilled syringe, 24 count, NDC 76045-0002-10
    • 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, 10 mL vial, 10 count, NDC 63323-0412-10
    • Midazolam injection, Fresenius Kabi, 5 mg/mL, 2 mL vial, 25 count, NDC 63323-0412-02
    • Midazolam injection, Hikma, 1 mg/mL, 100 mL premixed bag, 10 count, NDC 00143-9380-10
    • Midazolam injection, Hikma, 1 mg/mL, 2 mL vial, 25 count, NDC 00641-6057-25
    • Midazolam injection, Hikma, 1 mg/mL, 50 mL premixed bag, 10 count, NDC 00143-9379-10
    • 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, 2 mL preservative-free vial, 25 count, NDC 00409-0001-25
    • Midazolam injection, Pfizer, 1 mg/mL, 2 mL preservative-free vial, 25 count, NDC 00409-2305-17
    • Midazolam injection, Pfizer, 1 mg/mL, 5 mL preservative-free vial, 10 count, NDC 00409-2305-05
    • Midazolam injection, Pfizer, 5 mg/mL, 1 mL preservative-free vial, 10 count, NDC 00409-2308-01
    • Midazolam injection, Pfizer, 5 mg/mL, 10 mL vial, 10 count, NDC 00409-2596-05
    • Midazolam injection, Pfizer, 5 mg/mL, 2 mL preservative-free vial, 10 count, NDC 00409-2308-02
    • Midazolam injection, Pfizer, 5 mg/mL, 5 mL vial, 10 count, NDC 00409-2596-03
    • Midazolam injection, Sagent, 1 mg/mL, 2 mL preservative-free vial, 10 count, NDC 25021-0655-02
    • Midazolam injection, Somerset Therapeutics LLC, 1 mg/mL, 2 mL vial, 10 count, NDC 70069-0816-10
    • Midazolam injection, Somerset Therapeutics LLC, 1 mg/mL, 5 mL vial, 10 count, NDC 70069-0817-10
    • 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

    • Hikma has midazolam 1 mg/mL 10 mL vials on back order and the company estimates a release date of late-April to early-May 2025. The 5 mg/mL 10 mL vials are on back order and the company estimates a release date of early-April 2025. The 1 mg/mL 2 mL prefilled syringes are on back order and the company cannot estimate a release date. There are short-dated 5 mg/mL 2 mL syringes available with an expiration date of September 2025.
    • Sagent has midazolam 5 mg/mL 10 mL vials on back order and the company estimates a release date of September 2025.

Updated

Updated April 9, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 25, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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