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Labetalol Injection Shortage

Last Updated: April 24, 2024
Status: Current

Products Affected - Description
    • Labetalol injection, Baxter, 5 mg/mL, 4 mL vial, 10 count, NDC 36000-0320-10
    • Labetalol injection, Hikma, 5 mg/mL, 2 mL syringe, 10 count, NDC 00641-6252-10
    • Labetalol injection, Hikma, 5 mg/mL, 20 mL vial, 1 count, NDC 00143-9622-01
    • Labetalol injection, Hikma, 5 mg/mL, 40 mL vial, 1 count, NDC 00143-9623-01
    • Labetalol injection, Sagent, 5 mg/mL, 20 mL vial, 1 count, NDC 25021-0317-20
    • Labetalol injection, Sagent, 5 mg/mL, 40 mL vial, 1 count, NDC 25021-0317-40
Reason for the Shortage
    • Almaject has updated labetalol NDC numbers. The company has labetalol injection available.
    • Baxter has labetalol injection on shortage due to increased demand and third party supplier issues.
    • Fosun has labetalol injection available.
    • Hikma did not provide a reason for the shortage. Hikma discontinued the premixed bags in mid-2023.
    • Pfizer had labetalol injection on shortage due to increased demand and manufacturing delays.
    • Sagent did not provide a reason for the shortage.
Available Products
    • Labetalol injection, Almaject, 5 mg/mL, 20 mL vial, 1 count, NDC 72611-0734-01
    • Labetalol injection, Almaject, 5 mg/mL, 40 mL vial, 1 count, NDC 72611-0738-01
    • Labetalol injection, Baxter, 5 mg/mL, 20 mL vial, 1 count, NDC 36000-0322-02
    • Labetalol injection, Baxter, 5 mg/mL, 40 mL vial, 1 count, NDC 36000-0324-02
    • Labetalol injection, Fosun Pharma, 5 mg/mL, 20 mL vial, 1 count, NDC 72266-0102-01
    • Labetalol injection, Fosun Pharma, 5 mg/mL, 40 mL vial, 1 count, NDC 72266-0103-01
    • Labetalol injection, Pfizer, 5 mg/mL, 20 mL vial, 25 count, NDC 00409-0125-25
    • Labetalol injection, Pfizer, 5 mg/mL, 4 mL Carpuject syringe, 10 count, NDC 00409-2339-34
    • Labetalol injection, Pfizer, 5 mg/mL, 40 mL vial, 1 count, NDC 00409-2267-54

Estimated Resupply Dates

    • Baxter has labetalol 5 mg/mL 4 mL vials available in limited supply.
    • Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the company estimates a release date of late-September 2024. There are short-dated 2 mL syringes available with expiration date of October 2024.
    • Sagent has short-dated labetalol 5 mg/mL 40 mL vials available with an expiration date of May 2024. The 20 mL vials are on back order and the company estimates a release date of April 2024.

Updated

Updated April 24, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 19, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.