3/24/2024

Dofetilide Capsules

Products Affected - Description

- 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, 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 dofetilide 125 mcg capsules available. The 250 mcg and 500 mcg products were discontinued.
- Pfizer has Tikosyn capsules available.

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, bottle, 60 count, NDC 00069-5810-60
- 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, 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
- Dofetilide oral capsule, Sun Pharma, 125 mcg, bottle, 60 count, NDC 47335-0061-86

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.

Updated

Updated March 24, 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

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