Medicine
Flecainide 50 mg tablet
Flecainide 50 mg tablet is a generic prescription medicine for oral use, made by 15 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).
Key facts
- Active ingredient (INN)
- Flecainide
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1000 tablets and 40 more
- Manufacturers
- Aurobindo PharmaIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackA-S Medication SolutionsHikma PharmaceuticalsAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkANI PharmaceuticalsAvPAKChartwell RX15 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- 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 886662, 886666, 886671DailyMed set ID f0416c8c-faae-4e31-aa50-1fb7df10abf0, 5cfa10ba-dfe8-42ab-81b3-8cca657aba07, f53e1a49-6185-6db4-c867-ffd1241a8cb7 +19NDC 71335-1487, 71335-2995, 50268-320 +19Application ANDA075882, ANDA215599, 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
A sample of 40 packs from 15 labelers. The register lists 43 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 65862-621-01 | Aurobindo PharmaIndia | 3 November 2017 |
| 30 tablet in 1 bottle | 65862-621-30 | Aurobindo PharmaIndia | 3 November 2017 |
| 1000 tablet in 1 bottle | 65862-621-99 | Aurobindo PharmaIndia | 3 November 2017 |
| 100 tablet in 1 bottle | 76385-145-01 | Unichem LaboratoriesIndia | 11 January 2024 |
| 60 tablet in 1 bottle | 76385-145-60 | Unichem LaboratoriesIndia | 11 January 2024 |
| 100 tablet in 1 bottle | 65162-641-10 | Amneal Pharmaceuticals | 1 December 2009 |
| 1000 tablet in 1 bottle | 65162-641-11 | Amneal Pharmaceuticals | 1 December 2009 |
| 100 tablet in 1 bottle | 53746-641-01 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 1000 tablet in 1 bottle | 53746-641-10 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 100 tablet in 1 bottle | 62559-380-01 | ANI Pharmaceuticals | 28 December 2015 |
| 60 tablet in 1 bottle, glass | 62135-660-60 | Chartwell RX | 21 June 2023 |
| 100 tablet in 1 bottle | 42806-817-01 | Epic Pharma | 15 September 2022 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0054-0010-20 | Hikma Pharmaceuticals | 14 January 2003 |
| 60 tablet in 1 bottle | 0054-0010-21 | Hikma Pharmaceuticals | 14 January 2003 |
| 100 tablet in 1 bottle | 0054-0010-25 | Hikma Pharmaceuticals | 14 January 2003 |
| 100 tablet in 1 bottle | 57237-063-01 | Rising Pharma Holdings | 8 July 2015 |
| 100 tablet in 1 bottle | 63629-1946-1 | Bryant Ranch Prepack | 14 January 2021 |
| 30 tablet in 1 bottle | 63629-7979-1 | Bryant Ranch Prepack | 9 May 2019 |
| 60 tablet in 1 bottle | 63629-7979-2 | Bryant Ranch Prepack | 28 March 2019 |
| 90 tablet in 1 bottle | 63629-7979-3 | Bryant Ranch Prepack | 7 January 2021 |
| 10 tablet in 1 bottle | 63629-7979-4 | Bryant Ranch Prepack | 3 April 2024 |
| 180 tablet in 1 bottle | 63629-7979-5 | Bryant Ranch Prepack | 28 September 2022 |
| 100 tablet in 1 bottle | 63629-9184-1 | Bryant Ranch Prepack | 3 August 2022 |
| 30 tablet in 1 bottle | 71335-1487-1 | Bryant Ranch Prepack | 17 January 2020 |
| 60 tablet in 1 bottle | 71335-1487-2 | Bryant Ranch Prepack | 19 March 2020 |
| 90 tablet in 1 bottle | 71335-1487-3 | Bryant Ranch Prepack | 28 December 2021 |
| 10 tablet in 1 bottle | 71335-1487-4 | Bryant Ranch Prepack | 28 December 2021 |
| 180 tablet in 1 bottle | 71335-1487-5 | Bryant Ranch Prepack | 23 September 2025 |
| 30 tablet in 1 bottle | 71335-2995-1 | Bryant Ranch Prepack | 4 February 2026 |
| 60 tablet in 1 bottle | 71335-2995-2 | Bryant Ranch Prepack | 4 February 2026 |
| 90 tablet in 1 bottle | 71335-2995-3 | Bryant Ranch Prepack | 4 February 2026 |
| 10 tablet in 1 bottle | 71335-2995-4 | Bryant Ranch Prepack | 4 February 2026 |
| 180 tablet in 1 bottle | 71335-2995-5 | Bryant Ranch Prepack | 4 February 2026 |
| 100 tablet in 1 bottle | 72162-1760-1 | Bryant Ranch Prepack | 30 August 2023 |
| 60 tablet in 1 bottle | 50090-5306-0 | A-S Medication Solutions | 28 October 2020 |
| 60 tablet in 1 bottle | 50090-6035-0 | A-S Medication Solutions | 12 July 2022 |
| 60 tablet in 1 bottle | 50090-6810-0 | A-S Medication Solutions | 8 November 2023 |
| 50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 50268-320-15 | AvPAK | 12 February 2015 |
| 100 tablet in 1 bottle | 51407-018-01 | Golden State Medical Supply | 1 January 2018 |
| 100 tablet in 1 bottle, plastic | 72789-385-01 | PD-Rx Pharmaceuticals | 27 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 50 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.