Pillstats
Rx only · Capsule · Oral

Dofetilide

Brands: Tikosyn · Dofetilide

12 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US34 NDCs
12 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATCC01BD04
RxCUI (US)49247
US makers12 labelers
Packages46
DEA / ScheduleNone

US acquisition costNADAC · per unit

Average across 29 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.

$0.057$0.115$0.172$0.230Dec 2025Apr 2026Jul 2026
$0.193
Latest avg · Jul 22, 2026
-3%
Since Dec 17, 2025
12
Active US suppliers
26%
Top-2 supplier share*

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

1.9K3.7K5.6K7.5K2025 Q12025 Q22025 Q32025 Q42026 Q1
5.4K
Rx · 2026 Q1
459K
Units dispensed
-15%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it12 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Aurobindo Pharma Limitedunknown6SUPPLYING
SUN PHARMACEUTICAL INDUSTRIES, INC.unknown6SUPPLYING
Pfizer Laboratories Div Pfizer Incunknown6SUPPLYING
Novadoz Pharmaceuticals LLCunknown6SUPPLYING
Dr.Reddy's laboratories Limitedunknown3SUPPLYING
SIGMAPHARM LABORATORIES, LLCunknown3SUPPLYING
Bionpharma Inc.unknown3SUPPLYING
Accord Healthcare Inc.unknown3SUPPLYING
NorthStar RxLLCunknown3SUPPLYING
Exelan Pharmaceuticals, Inc.unknown3SUPPLYING
Major Pharmaceuticalsunknown3SUPPLYING
REMEDYREPACK INC.repackager1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Jul 18, 2023
    RECALLRecall (Class III): Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, S…

    Out of Specification result observed in content uniformity testing — Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC — Nationwide in the USA

  • Feb 7, 2023
    RECALLRecall (Class II): Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, N…

    CGMP Deviations: recalling drug products following an FDA inspection. — Recalling firm: Accord Healthcare, Inc. — United States including Puerto Rico and Canada

  • Feb 7, 2023
    RECALLRecall (Class II): Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 2…

    CGMP Deviations: recalling drug products following an FDA inspection. — Recalling firm: Accord Healthcare, Inc. — United States including Puerto Rico and Canada

  • Feb 7, 2023
    RECALLRecall (Class II): Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 2…

    CGMP Deviations: recalling drug products following an FDA inspection. — Recalling firm: Accord Healthcare, Inc. — United States including Puerto Rico and Canada

  • Dec 3, 2014
    RECALLRecall (Class II): Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), …

    Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. — Recalling firm: Pfizer Inc. — Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected …