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Dexmedetomidine Hydrochloride Injection

Last Updated: June 20, 2018
Status: Current

Products Affected - Description
    • Precedex in 0.9% Sodium Chloride Injection solution for injection, Pfizer, 4 mcg/mL, 100 mL glass bottle, 10 count, NDC 00409-1660-10
    • Precedex in 0.9% Sodium Chloride Injection solution for injection, Pfizer, 4 mcg/mL, 20 mL glass vial, 10 count, NDC 00409-1660-20
    • Precedex in 0.9% Sodium Chloride Injection solution for injection, Pfizer, 4 mcg/mL, 50 mL glass bottle, 20 count, NDC 00409-1660-50
    • Dexmedetomidine Hydrochloride solution for injection, Akorn, 100 mcg/mL, 2 mL single dose vial, 10 count, NDC 17478-0055-02
Reason for the Shortage
    • Akorn did not provide a reason for the shortage.
    • Athenex has dexmedetomidine vials available.
    • Fresenius Kabi has dexmedetomidine vials available.
    • Mylan has dexmedetomidine vials available.
    • Par has dexmedetomidine vials available.
    • Pfizer did not provide a reason for the shortage.
    • Sandoz has dexmedetomidine vials available.
    • Teva has dexmedetomidine vials available.
    • West-Ward has dexmedetomidine vials available.
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, 10 count, NDC 70860-0605-02
    • 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, Fresenius Kabi, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 63323-0421-02
    • 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, Par Pharmaceuticals, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 42023-0146-25
    • Dexmedetomidine Hydrochloride solution for injection, Sandoz, 100 mcg/mL, 2 mL single dose vial, 10 count, NDC 00781-3297-95
    • Dexmedetomidine Hydrochloride solution for injection, Teva, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 45963-0906-42
    • Dexmedetomidine Hydrochloride solution for injection, West-Ward, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00143-9532-25

Estimated Resupply Dates

    • Akorn has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates a release date in late-June 2018. Short-dated product (expiry December 2018) is available.
    • Pfizer has Precedex 4 mcg/mL 50 mL and 100 mL premixed bottles on back order and the company estimates a release date in June 2018. The 4 mcg/mL 20 mL vials are on back order and the company estimates a release date in July 2018.

Updated

Updated June 20, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created February 15, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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