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10/5/2021

Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection

Products Affected - Description

    • Dexmedetomidine hydrochloride solution for injection, AuroMedics, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 55150-0209-02
    • Dexmedetomidine hydrochloride solution for injection, Mylan, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 67457-0251-02
    • Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 100 mcg/mL, 10 mL single dose vial, 4 count, NDC 44567-0601-04

Reason for the Shortage

    • Accord has dexmedetomidine vials available.
    • Akorn is no longer manufacturing dexmedetomidine vials.
    • Athenex has dexmedetomidine vials available.
    • AuroMedics did not provide a reason for the shortage.
    • Fresenius Kabi has dexmedetomidine vials available.
    • Hikma did not provide a reason for the shortage.
    • Mylan did not provide a reason for the shortage.
    • Par has dexmedetomidine vials available.
    • Pfizer has dexmedetomidine vials available.
    • Piramal has dexmedetomidine vials available.
    • Sandoz discontinued dexmedetomidine vials in April 2020.
    • Sun Pharma is no longer manufacturing dexmedetomidine.
    • WG Critical Care has dexmedetomidine on shortage due to increased demand.

Available Products

    • Precedex solution for injection, Pfizer, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00409-1638-02
    • Dexmedetomidine hydrochloride solution for injection, Accord, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 16729-0239-93
    • Dexmedetomidine hydrochloride solution for injection, Athenex, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 70860-0605-03
    • Dexmedetomidine hydrochloride solution for injection, Fresenius Kabi, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 63323-0421-02
    • Dexmedetomidine hydrochloride solution for injection, Hikma, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00143-9532-25
    • Dexmedetomidine hydrochloride solution for injection, Par Pharmaceuticals, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 42023-0146-25
    • Dexmedetomidine hydrochloride solution for injection, Piramal Critical Care, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 66794-0233-02
    • Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 100 mcg/mL, 4 mL single dose vial, 4 count, NDC 44567-0600-04

Estimated Resupply Dates

    • AuroMedics has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the company is releasing product as it becomes available.
    • WG Critical Care has dexmedetomidine 100 mcg/mL 10 mL vials on allocation.
    • Mylan has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates a release date of mid- to late-October 2021.

Updated

Updated October 5, 2021 by Leslie Jensen, PharmD, Drug Information Specialist. Created November 8, 2018 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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