Medicine
Propafenone 225 mg extended-release capsule
Propafenone 225 mg extended-release capsule is a generic prescription medicine for oral use, made by 7 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)
- Propafenone
- Brand
- Sold under the generic name
- Strength
- 225 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 500 capsules, 60 capsules, 90 capsules and 10 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaRising Pharma HoldingsVitruvias TherapeuticsNorthStar Rx7 labelers on the register
- 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).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 March 2017
- Identifiers
- RxCUI 861156, 861164, 861171DailyMed set ID 2ecd6452-ccc3-493f-9a4a-69f0fbf67a42, b41ec863-5734-41a3-9837-6c0a962ec6eb, 8aa6f58a-2980-4caa-9c54-d55d69d5d132 +5NDC 16714-825, 70771-1525, 0832-0740 +5Application ANDA205268, ANDA214184, ANDA212744 +3
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 |
|---|---|---|---|
| 500 capsule, extended release in 1 bottle | 68382-522-05 | Zydus LifesciencesIndia | 2 February 2022 |
| 60 capsule, extended release in 1 bottle | 68382-522-14 | Zydus LifesciencesIndia | 2 February 2022 |
| 500 capsule, extended release in 1 bottle | 70771-1525-5 | Zydus LifesciencesIndia | 2 February 2022 |
| 60 capsule, extended release in 1 bottle | 70771-1525-6 | Zydus LifesciencesIndia | 2 February 2022 |
| 500 capsule, extended release in 1 bottle | 59651-276-05 | Aurobindo PharmaIndia | 21 February 2023 |
| 60 capsule, extended release in 1 bottle | 59651-276-60 | Aurobindo PharmaIndia | 21 February 2023 |
| 90 capsule, extended release in 1 bottle | 59651-276-90 | Aurobindo PharmaIndia | 21 February 2023 |
| 60 capsule, extended release in 1 bottle | 68462-408-60 | Glenmark PharmaceuticalsIndia | 8 September 2017 |
| 60 capsule, extended release in 1 bottle | 16571-736-06 | Rising Pharma Holdings | 16 December 2020 |
| 500 capsule, extended release in 1 bottle | 16571-736-50 | Rising Pharma Holdings | 16 December 2020 |
| 60 capsule, extended release in 1 bottle, plastic | 69680-130-60 | Vitruvias Therapeutics | 28 January 2019 |
| 500 capsule, extended release in 1 bottle, plastic | 69680-130-92 | Vitruvias Therapeutics | 28 January 2019 |
| 60 capsule, extended release in 1 bottle | 16714-825-01 | Northstar Rx | 16 July 2018 |
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 27 November 1989 | 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 Propafenone
Clinical summary
Propafenone is an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease, among other approved uses. MedsAcross supplies Propafenone 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 PropafenoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- propafenone hydrochloride prescribing information (Northstar Rx) · U.S. National Library of Medicine, DailyMed
Need Propafenone 225 mg extended-release 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.