NDC 0069-5810

Tikosyn 0.25 mg capsule

On the label: Pfizer Laboratories Div Pfizer Inc.

Ireland: 1Italy: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Pfizer Ireland Pharmaceuticals Unlimited CompanyRingaskiddy, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections
Pfizer Italia S.r.l.Ascoli Piceno, ItalyMakes it, tests it and packages it Problems found, fixed voluntarilyMar 14, 2025 · 5 inspections

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Dofetilide: every company that makes it
Form
capsule, oral
Strength
0.25 mg
Approval
NDA NDA020931
On the market since
Oct 1, 1999
Package NDCs
0069-5810-43 0069-5810-60 0069-5810-61
Official label
DailyMed (National Library of Medicine), updated Apr 21, 2026

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