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7/14/2024

Dofetilide Capsules

Products Affected - Description

    • Tikosyn oral capsule, Pfizer, 125 mcg, bottle, 60 count, NDC 00069-5800-60
    • Tikosyn oral capsule, Pfizer, 250 mcg, bottle, 60 count, NDC 00069-5810-60
    • Tikosyn oral capsule, Pfizer, 500 mcg, bottle, 60 count, NDC 00069-5820-60
    • Dofetilide oral capsule, Accord, 125 mcg, bottle, 60 count, NDC 16729-0490-12
    • Dofetilide oral capsule, Accord, 250 mcg, bottle, 60 count, NDC 16729-0491-12
    • Dofetilide oral capsule, Accord, 500 mcg, bottle, 60 count, NDC 16729-0492-12
    • Dofetilide oral capsule, Mayne Pharma, 125 mcg, bottle, 60 count, NDC 51862-0125-60
    • Dofetilide oral capsule, Mayne Pharma, 250 mcg, bottle, 60 count, NDC 51862-0025-60
    • Dofetilide oral capsule, Mayne Pharma, 500 mcg, bottle, 60 count, NDC 51862-0005-60
    • Dofetilide oral capsule, Sun Pharma, 125 mcg, bottle, 60 count, NDC 47335-0061-86 - discontinued
    • Dofetilide oral capsule, Sun Pharma, 250 mcg, bottle, 60 count, NDC 47335-0062-86 - discontinued
    • Dofetilide oral capsule, Sun Pharma, 500 mcg, bottle, 60 count, NDC 47335-0063-86 - discontinued

Reason for the Shortage

    • Accord has dofetilide on shortage due to manufacturing delays.
    • BionPharma has dofetilide capsules available.
    • Major has dofetilide presentations available.
    • Mayne Pharma has dofetilide on shortage due to problems with obtaining active ingredient.
    • Novadoz has dofetilide capsules available.
    • Sun has discontinued dofetilide 125 mcg, 250 mcg and 500 mcg products.
    • Pfizer has Tikosyn on shortage due to manufacturing delays.

Available Products

    • Tikosyn oral capsule, Pfizer, 125 mcg, unit-dose blister pack, 40 count, NDC 00069-5800-43
    • Tikosyn oral capsule, Pfizer, 250 mcg, unit-dose blister pack, 40 count, NDC 00069-5810-43
    • Tikosyn oral capsule, Pfizer, 500 mcg, unit-dose blister pack, 40 count, NDC 00069-5820-43
    • Dofetilide oral capsule, Bionpharma, 125 mcg, bottle, 60 count, NDC 69452-0131-17
    • Dofetilide oral capsule, Bionpharma, 250 mcg, bottle, 60 count, NDC 69452-0132-17
    • Dofetilide oral capsule, Bionpharma, 500 mcg, bottle, 60 count, NDC 69452-0133-17
    • Dofetilide oral capsule, Major, 125 mcg, unit-dose blister pack, 40 count, NDC 00904-6681-08
    • Dofetilide oral capsule, Major, 250 mcg, unit-dose blister pack, 40 count, NDC 00904-6682-08
    • Dofetilide oral capsule, Major, 500 mcg, unit-dose blister pack, 40 count, NDC 00904-6683-08
    • Dofetilide oral capsule, Novadoz, 125 mcg, bottle, 60 count, NDC 72205-0039-60
    • Dofetilide oral capsule, Novadoz, 250 mcg, bottle, 60 count, NDC 72205-0040-60
    • Dofetilide oral capsule, Novadoz, 500 mcg, bottle, 60 count, NDC 72205-0041-60

Estimated Resupply Dates

    • Accord has dofetilide capsules on back order and the company cannot estimate when manufacturing will resume.
    • Mayne Pharma has dofetilide 125 mcg, 250 mcg, and 500 mcg capsules on back order and the company cannot estimate a release date.
    • Pfizer has Tikosyn 125 mcg, 250 mcg, and 500 mcg capsules in 60 count bottles available in limited supply.

Updated

Updated July 14, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created April 26, 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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