Medicine
Dofetilide 0.125 mg capsule
Dofetilide 0.125 mg capsule is a generic prescription medicine for oral use, made by 12 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 15° to 30° C (59° to 86° F). PROTECT FROM MOISTURE AND HUMIDITY.
Key facts
- Active ingredient (INN)
- Dofetilide
- Brand
- Sold under the generic name
- Strength
- 0.125 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 500 capsules, 4 blister pack and 13 more
- Manufacturers
- Aurobindo PharmaIndiaNovadoz PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaDr. Reddy's LaboratoriesIndiaGranules IndiaIndiaRemedyrepackBionpharmaExelan PharmaceuticalsMajor Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 15° to 30° C (59° to 86° F). PROTECT FROM MOISTURE AND HUMIDITY.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BD04 Dofetilide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 April 2018
- Identifiers
- RxCUI 310003, 310004, 310005DailyMed set ID b8323987-90fe-4e6c-a71c-76e3c501713c, 0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1, cff8d66a-ed43-46dd-97de-3dd21a7f2572 +9NDC 72205-039, 69452-131, 70518-4738 +9Application ANDA213220, ANDA208625, ANDA207746 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule in 1 bottle | 16729-490-12 | Accord HealthcareIndia | 20 August 2020 |
| 500 capsule in 1 bottle | 59651-118-05 | Aurobindo PharmaIndia | 22 January 2019 |
| 60 capsule in 1 bottle | 59651-118-60 | Aurobindo PharmaIndia | 22 January 2019 |
| 60 capsule in 1 bottle, plastic | 75907-056-60 | Dr. Reddy's LaboratoriesIndia | 28 May 2024 |
| 60 capsule in 1 bottle | 70010-024-06 | Granules IndiaIndia | 14 November 2024 |
| 4 blister pack in 1 carton / 10 capsule in 1 blister pack | 72205-039-37 | Novadoz PharmaceuticalsIndia | 12 June 2020 |
| 60 capsule in 1 bottle | 72205-039-60 | Novadoz PharmaceuticalsIndia | 12 June 2020 |
| 4 blister pack in 1 carton / 10 capsule in 1 blister pack | 47335-061-79 | Sun Pharmaceutical IndustriesIndia | 11 October 2018 |
| 60 capsule in 1 bottle | 47335-061-86 | Sun Pharmaceutical IndustriesIndia | 11 October 2018 |
| 60 capsule in 1 bottle | 69452-131-17 | Bionpharma | 11 April 2018 |
| 60 capsule in 1 bottle | 76282-755-60 | Exelan Pharmaceuticals | 1 November 2024 |
| 60 capsule in 1 bottle, plastic | 42794-044-10 | Sigmapharm Laboratories | 11 June 2018 |
| 40 blister pack in 1 carton / 1 capsule in 1 blister pack | 0904-7522-08 | Major Pharmaceuticals | 17 October 2024 |
| 60 capsule in 1 bottle | 72603-130-01 | NorthStar RxLLC | 7 February 2023 |
| 100 pouch in 1 box / 1 capsule in 1 pouch | 70518-4738-0 | Remedyrepack | 26 August 2026 |
| 50 pouch in 1 box / 1 capsule in 1 pouch | 70518-4738-1 | Remedyrepack | 26 August 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Dofetilide 0.125 mg capsule.
Other strengths and forms of Dofetilide
Clinical summary
Dofetilide is an antiarrhythmic 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. MedsAcross supplies Dofetilide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DofetilideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tikosyn prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Dofetilide 0.125 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.