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Budesonide Suspension for Inhalation Shortage

Last Updated: May 2, 2024
Status: Current

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.

Further information

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