Medicine
Flecainide 100 mg tablet
Flecainide 100 mg tablet is a generic prescription medicine for oral use, made by 14 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Flecainide
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1000 tablets and 36 more
- Manufacturers
- Aurobindo PharmaIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackHikma PharmaceuticalsPD-Rx PharmaceuticalsAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkGolden State Medical SupplyA-S Medication SolutionsANI Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BC04 Flecainide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 October 2002
- Identifiers
- RxCUI 886666, 886662, 886671DailyMed set ID 8a900f29-85e1-464c-ae9e-44dc7cf11f46, e56335c1-5508-4136-bd2e-18385623e497, d462d58e-fc3c-4c92-a210-e135eb1f4b77 +15NDC 71335-3063, 57237-064, 65162-642 +15Application ANDA215599, ANDA202821, ANDA075442 +4
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 65862-622-01 | Aurobindo PharmaIndia | 3 November 2017 |
| 30 tablet in 1 bottle | 65862-622-30 | Aurobindo PharmaIndia | 3 November 2017 |
| 1000 tablet in 1 bottle | 65862-622-99 | Aurobindo PharmaIndia | 3 November 2017 |
| 100 tablet in 1 bottle | 76385-146-01 | Unichem LaboratoriesIndia | 11 January 2024 |
| 60 tablet in 1 bottle | 76385-146-60 | Unichem LaboratoriesIndia | 11 January 2024 |
| 100 tablet in 1 bottle | 65162-642-10 | Amneal Pharmaceuticals | 1 December 2009 |
| 1000 tablet in 1 bottle | 65162-642-11 | Amneal Pharmaceuticals | 1 December 2009 |
| 100 tablet in 1 bottle | 53746-642-01 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 1000 tablet in 1 bottle | 53746-642-10 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 100 tablet in 1 bottle | 62559-381-01 | ANI Pharmaceuticals | 28 December 2015 |
| 60 tablet in 1 bottle, glass | 62135-661-60 | Chartwell RX | 21 June 2023 |
| 100 tablet in 1 bottle | 42806-818-01 | Epic Pharma | 15 September 2022 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0054-0011-20 | Hikma Pharmaceuticals | 14 January 2003 |
| 60 tablet in 1 bottle | 0054-0011-21 | Hikma Pharmaceuticals | 14 January 2003 |
| 100 tablet in 1 bottle | 0054-0011-25 | Hikma Pharmaceuticals | 14 January 2003 |
| 100 tablet in 1 bottle | 57237-064-01 | Rising Pharma Holdings | 8 July 2015 |
| 100 tablet in 1 bottle | 63629-1945-1 | Bryant Ranch Prepack | 14 January 2021 |
| 30 tablet in 1 bottle | 63629-7982-1 | Bryant Ranch Prepack | 2 April 2019 |
| 60 tablet in 1 bottle | 63629-7982-2 | Bryant Ranch Prepack | 7 May 2019 |
| 90 tablet in 1 bottle | 63629-7982-3 | Bryant Ranch Prepack | 6 October 2021 |
| 180 tablet in 1 bottle | 63629-7982-4 | Bryant Ranch Prepack | 3 April 2024 |
| 30 tablet in 1 bottle | 71335-2577-1 | Bryant Ranch Prepack | 5 February 2025 |
| 60 tablet in 1 bottle | 71335-2577-2 | Bryant Ranch Prepack | 5 February 2025 |
| 90 tablet in 1 bottle | 71335-2577-3 | Bryant Ranch Prepack | 5 February 2025 |
| 180 tablet in 1 bottle | 71335-2577-4 | Bryant Ranch Prepack | 5 February 2025 |
| 100 tablet in 1 bottle | 71335-2577-5 | Bryant Ranch Prepack | 5 February 2025 |
| 30 tablet in 1 bottle | 71335-3063-1 | Bryant Ranch Prepack | 6 February 2026 |
| 60 tablet in 1 bottle | 71335-3063-2 | Bryant Ranch Prepack | 6 February 2026 |
| 90 tablet in 1 bottle | 71335-3063-3 | Bryant Ranch Prepack | 6 February 2026 |
| 180 tablet in 1 bottle | 71335-3063-4 | Bryant Ranch Prepack | 6 February 2026 |
| 100 tablet in 1 bottle | 71335-3063-5 | Bryant Ranch Prepack | 6 February 2026 |
| 100 tablet in 1 bottle | 72162-1761-1 | Bryant Ranch Prepack | 4 October 2023 |
| 60 tablet in 1 bottle | 50090-2968-0 | A-S Medication Solutions | 7 April 2017 |
| 50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 50268-321-15 | AvPAK | 12 February 2015 |
| 100 tablet in 1 bottle | 51407-019-01 | Golden State Medical Supply | 1 January 2018 |
| 60 tablet in 1 bottle | 51407-019-60 | Golden State Medical Supply | 1 January 2018 |
| 100 tablet in 1 bottle, plastic | 72789-383-01 | PD-Rx Pharmaceuticals | 28 February 2024 |
| 60 tablet in 1 bottle, plastic | 72789-383-60 | PD-Rx Pharmaceuticals | 27 February 2024 |
| 180 tablet in 1 bottle, plastic | 72789-383-93 | PD-Rx Pharmaceuticals | 28 February 2024 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 31 October 1985 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Other strengths and forms of Flecainide
Clinical summary
Flecainide is an antiarrhythmic indicated for the prevention of - paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Flecainide 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 FlecainideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Flecainide Acetate prescribing information (Amneal Pharmaceuticals of New York) · U.S. National Library of Medicine, DailyMed
Need Flecainide 100 mg tablet 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.