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1/18/2024

Zoledronic Acid Injection

Products Affected - Description

    • Zoledronic Acid intravenous concentrate, Pfizer, 4 mg/5 mL, 5 mL single dose vial, NDC 00409-4215-01 - discontinued
    • Zoledronic Acid intravenous concentrate, Sagent, 4 mg/5 mL, 5 mL single dose vial, NDC 25021-0801-66 - discontinued
    • Zoledronic Acid intravenous solution for injection, Sagent, 4 mg/100 mL, 100 mL bottle, NDC 70860-0210-51

Reason for the Shortage

    • Athenex has product available.
    • Dr. Reddy's has zoledronic acid injection available.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Mylan (Viatris) did not provide a reason for the shortage.
    • Novartis has Reclast available.
    • Pfizer discontinued zoledronic acid in late-2023.
    • Sagent has zoledronic acid available. Sagent discontinued the 4 mg/mL 5 mL vials in late-2023.

Available Products

    • Reclast intravenous solution for injection, Sandoz, 5 mg/100 mL, 100 mL bottle, NDC 00078-0435-61
    • Zoledronic Acid intravenous concentrate, Dr. Reddy's, 4 mg/5 mL, 5 mL single dose vial, NDC 55111-0685-07
    • Zoledronic Acid intravenous solution for injection, Dr. Reddy's, 5 mg/100 mL, 100 mL bottle, NDC 55111-0688-52
    • Zoledronic Acid intravenous concentrate, Fresenius Kabi, 4 mg/5 mL, 5 mL single dose vial, NDC 63323-0961-98
    • Zoledronic Acid intravenous solution for injection, Fresenius Kabi, 5 mg/100 mL, 100 mL glass vial, NDC 63323-0966-00
    • Zoledronic Acid intravenous concentrate, Mylan (Viatris), 4 mg/5 mL, 5 mL single dose vial, NDC 67457-0390-54
    • Zoledronic Acid intravenous solution for injection, Mylan (Viatris), 5 mg/100 mL, 100 mL bag, NDC 67457-0794-10
    • Zoledronic Acid intravenous solution for injection, Mylan (Viatris), 5 mg/100 mL, 100 mL vial, NDC 67457-0619-10
    • Zoledronic Acid intravenous solution for injection, Sagent, 4 mg/100 mL, 100 mL bag, NDC 25021-0826-82
    • Zoledronic Acid intravenous solution for injection, Sagent, 5 mg/100 mL, 100 mL bag, NDC 25021-0830-82

Estimated Resupply Dates

    • Sagent has zoledronic acid 4 mg/100 mL bottles on back order and the company cannot estimate a release date.

Updated

Updated January 18, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 21, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, 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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