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.

Disclaimer

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