Quick answers
- What is Tikosyn?
- Tikosyn is a brand name of Dofetilide, a prescription medicine. The FDA NDC Directory lists 3 Tikosyn products in 3 strengths and forms.
- Who makes Tikosyn?
- Pfizer holds the FDA application for Tikosyn (NDA020931, approved October 1, 1999).
- Is there a generic or store brand of Tikosyn?
- Yes. The FDA NDC Directory lists 32 other products with the same active ingredients, strength and form as a Tikosyn product, 32 of them generic. Ask your pharmacist whether one is right for you.
- Has Tikosyn been recalled?
- FDA enforcement reports list 1 recall of Tikosyn products; the newest started December 3, 2014. A recall usually concerns specific lots, not every product.
What Tikosyn is
Each Tikosyn product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dofetilide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dofetilide 0.125 mg capsule (oral) | Tikosyn | 11 products, 11 companies | DailyMed |
| dofetilide 0.25 mg capsule (oral) | Tikosyn | 11 products, 11 companies | DailyMed |
| dofetilide 0.5 mg capsule (oral) | Tikosyn | 10 products, 10 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dofetilide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020931 | Pfizer | October 1, 1999 | 3 |
Companies that list Tikosyn
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tikosyn products.
- Pfizer Laboratories Div Pfizer Inc3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 3, 2014 · Class II · Terminated · D-0292-2015
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017. — Pfizer Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.