10/18/2024

Dofetilide Capsules

Products Affected - Description

- Tikosyn oral capsule, Pfizer, 250 mcg, bottle, 60 count, NDC 00069-5810-60
- 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, 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, 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 did not provide a reason for the shortage.
- 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, bottle, 60 count, NDC 00069-5800-60
- 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, bottle, 60 count, NDC 00069-5820-60
- 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, 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.
- Major has dofetilide 125 mcg and 250 mcg in 40 count unit-dose packages on back order and the company cannot estimate a release date.
- 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 250 mcg mcg capsules in 60 count bottles available in limited supply.

Updated

Updated October 18, 2024 by Leslie Jensen, PharmD, Drug Information Specialist. Created April 26, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

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