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5/2/2024

Budesonide Suspension for Inhalation

Products Affected - Description

    • Budesonide inhalation suspension, Amneal, 0.25 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00115-1687-74 - discontinued
    • Budesonide inhalation suspension, Amneal, 0.5 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00115-1689-74 - discontinued
    • Budesonide inhalation suspension, Cipla USA, 0.25 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 69097-0318-53
    • Budesonide inhalation suspension, Cipla USA, 0.25 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 69097-0318-87
    • Budesonide inhalation suspension, Lupin, 0.5 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 68180-0984-30
    • Budesonide inhalation suspension, Nephron Pharmaceuticals Corporation, 0.5 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00487-9701-01
    • Budesonide inhalation suspension, Nephron Pharmaceuticals Corporation, 0.5 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 00487-9701-30
    • Budesonide inhalation suspension, Teva, 0.25 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 00093-6815-55
    • Budesonide inhalation suspension, Teva, 0.25 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00093-6815-73
    • Budesonide inhalation suspension, Teva, 0.5 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00093-6816-73
    • Budesonide inhalation suspension, Teva, 0.5 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 00093-6816-55
    • Budesonide inhalation suspension, Teva, 1 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00093-6817-73

Reason for the Shortage

    • Amneal has discontinued budesonide inhalation suspension.
    • AstraZeneca states Pulmicort Respules are available.
    • Cipla did not provide a reason for the shortage.
    • Lupin did not provide a reason for the shortage.
    • Nephron is prioritizing the production of albuterol inhalation solution.
    • Sandoz did not provide a reason for the shortage.
    • Teva did not provide a reason for the shortage.

Available Products

    • Budesonide inhalation suspension, Cipla USA, 0.5 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 69097-0319-53
    • Budesonide inhalation suspension, Cipla USA, 0.5 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 69097-0319-87
    • Budesonide inhalation suspension, Cipla USA, 1 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 69097-0321-87
    • Budesonide inhalation suspension, Cipla USA, 1 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 69097-0321-53
    • Budesonide inhalation suspension, Nephron Pharmaceuticals Corporation, 0.25 mg / 2 mL, single-dose ampules in individual pouches, 30 count, NDC 00487-9601-30
    • Budesonide inhalation suspension, Nephron Pharmaceuticals Corporation, 0.25 mg / 2 mL, 5 single-dose ampules per pouch, 6 pouches, 30 count, NDC 00487-9601-01

Estimated Resupply Dates

    • Cipla has budesonide 0.25 mg/2 mL (individually packaged) on back order and the company cannot estimate a release date. The 0.25 mg/2 mL (5 vials per pouch) presentations are available with short expiration dating.
    • Lupin has budesonide 0.5 mg/2 mL (5 vials per pouch) inhalation suspension on allocation.
    • Nephron has budesonide 0.5 mg/2 mL inhalation suspension on intermittent back order and the company is releasing supplies as they become available.
    • Sandoz has all budesonide inhalation suspension presentations temporarily unavailable.
    • Teva has budesonide inhalation 0.25 mg/2 mL vials (individually packaged) and 0.5 mg/2 mL (5 vials per pouch) on back order and the company cannot estimate a release date. The 0.25 mg/2 mL (5 vials per pouch) are on intermittent back order and the company is releasing supplies as they become available. The 0.5 mg/2 mL (individually packaged) and 1 mg/2mL (5 vials per pouch) are on back order and the company estimates a release date of mid- to late-June 2024 for the 0.5 mg/2 mL and late-June 2024 for the 1 mg/2mL presentation.

Updated

Updated May 2, 2024 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 30, 2023 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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