Skip to main content Back to Top
Advertisement

1/26/2024

Labetalol Injection

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, Hikma, In 0.72% sodium chloride 100 mg/100 mL premixed bag, 10 count, NDC 00143-9363-10 - discontinued
    • Labetalol injection, Hikma, In 0.72% sodium chloride 200 mg/200 mL premixed bag, 10 count, NDC 00143-9364-10 - discontinued
    • Labetalol injection, Hikma, In 5% dextrose 200 mg/200 mL premixed bag, 10 count, NDC 00143-9366-10 - discontinued
    • Labetalol injection, Hikma, In 0.72% sodium chloride 300 mg/300 mL premixed bag, 10 count, NDC 00143-9365-10 - discontinued
    • 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
    • Labetalol injection, Sagent, 5 mg/mL, 20 mL vial, 1 count, NDC 25021-0317-20

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. There are short-dated 5 mg/mL 40 mL vials and 2 mL syringes available with expiration date of July 2024 for the 40 mL vials and October 2024 for the 2 mL syringes.
    • Sagent has short-dated labetalol 5 mg/mL 40 mL vials available with an expiration date of May 2024.

Updated

Updated January 26, 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.

ADVERTISEMENT

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.

« Back to Drug Shortage Product Bulletins


ahfs logo

Subscribe to AHFS Clinical Drug Information to get direct access to integrated drug shortages content, plus comprehensive and actionable drug information.