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9/8/2025

Mometasone Furoate and Formoterol Fumarate Inhalation Aerosol

Products Affected - Description

    • Dulera metered spray, Organon, 100 mcg/5 mcg, 13 g inhaler, NDC 78206-0127-01
    • Dulera metered spray, Organon, 100 mcg/5 mcg, 8.8 g inhaler, NDC 78206-0127-02

Reason for the Shortage

    • Organon did not provide a reason for the shortage

Available Products

    • Dulera metered spray, Organon, 200 mcg/5 mcg, 8.8 g inhaler, NDC 78206-0126-02
    • Dulera metered spray, Organon, 200 mcg/5 mcg, 13 g inhaler, NDC 78206-0126-01
    • Dulera metered spray, Organon, 50 mcg/5 mcg, 13 g inhaler, NDC 78206-0125-01

Estimated Resupply Dates

    • Organon has Dulera inhalation aerosol in 100 mcg/5 mcg 8.8 gram inhalers on back order and the company estimates a release date of mid-October 2025. The 100 mcg/5 mcg 13 gram inhalers are on back order and the company estimates a release date of mid-September 2025.

Updated

Updated September 8, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 29, 2025 by Rachael Freeman, PharmD, BCPS. © 2025, 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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