Quick answers
- What is Dofetilide used for?
- The FDA-approved label (Tikosyn, Pfizer Laboratories Div Pfizer Inc, April 21, 2026) says: “Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dofetilide have a boxed warning?
- Yes. The FDA label for Tikosyn has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dofetilide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dofetilide been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started July 18, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Dofetilide?
- 13 companies list prescription products of Dofetilide in the FDA NDC Directory, including Dr. Reddy's Labratories Inc., Pfizer Laboratories Div Pfizer Inc and Accord Healthcare Inc..
What Dofetilide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. …
— FDA label: Tikosyn, Pfizer Laboratories Div Pfizer Inc, effective April 21, 2026. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
11 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 38 in the FDA NDC Directory |
| Brand names | Tikosyn |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dofetilide 0.125 mg capsule | Generic | $0.1979 per capsule |
| dofetilide 0.25 mg capsule | Generic | $0.1920 per capsule |
| dofetilide 0.5 mg capsule | Generic | $0.1872 per capsule |
| dofetilide 125 ug capsule | Generic | $0.1979 per capsule |
| dofetilide 250 ug capsule | Generic | $0.1920 per capsule |
| dofetilide 500 ug capsule | Generic | $0.1872 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Dr. Reddy's Labratories Inc.3 products
- Pfizer Laboratories Div Pfizer Inc3 products
- Accord Healthcare Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Bionpharma Inc.3 products
- Granules Pharmaceuticals Inc.3 products
- Novadoz Pharmaceuticals LLC3 products
- NorthStar RxLLC3 products
- Major Pharmaceuticals3 products
- Aurobindo Pharma Limited3 products
- Exelan Pharmaceuticals Inc.3 products
- Sigmapharm Laboratories, LLC3 products
- Remedyrepack Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020931 TIKOSYN | Pfizer | October 1, 1999 | 9, latest August 8, 2019 2019: Labeling · 2016: REMS · 2016: Labeling |
Generic approvals (8)
- ANDA207058DR Reddys Labs SA · June 6, 2016
- ANDA207746Sigmapharm Labs LLC · March 26, 2018
- ANDA208625Bionpharma · April 10, 2018
- ANDA210466Sun Pharm · October 9, 2018
- ANDA210740Aurobindo Pharma Ltd · January 22, 2019
- ANDA213220Msn · January 29, 2020
- ANDA213338Accord Hlthcare · June 19, 2020
- ANDA212750Granules · October 14, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 18, 2023 · Class III · Terminated · D-1082-2023
Out of Specification result observed in content uniformity testing
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industrie — SUN PHARMACEUTICAL INDUSTRIES INC
-
February 7, 2023 · Class II · Terminated · D-0385-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0384-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0383-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729 — Accord Healthcare, Inc.
-
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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tikosyn, Pfizer Laboratories Div Pfizer Inc, effective April 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →