Active substance
Propafenone
- US FDA 18
- Health Canada 6
- US price lines 6
- NHS prices 2
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE | 150MG; 225MG; 300MG | tablet · oral | STRIDES PHARMA INTL | Prescription | 17 Oct 2002 |
| PROPAFENONE HYDROCHLORIDE | 150MG; 225MG; 300MG | tablet · oral | ANI PHARMS | Prescription | 23 Apr 2004 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | STRIDES PHARMA INTL | Prescription | 18 Oct 2010 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | WATSON LABS INC | Prescription | 24 Aug 2015 |
| PROPAFENONE HYDROCHLORIDE | 150MG; 225MG; 300MG | tablet · oral | AUROBINDO PHARMA | Prescription | 11 May 2016 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | GLENMARK PHARMS LTD | Prescription | 8 Sep 2017 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | RISING | Prescription | 2 Jul 2018 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | SINOTHERAPEUTICS INC | Prescription | 4 Jan 2019 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | UPSHER SMITH LABS | Prescription | 25 Jun 2020 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | ZYDUS LIFESCIENCES | Prescription | 21 Apr 2021 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | AUROBINDO PHARMA LTD | Prescription | 21 Feb 2023 |
| RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | GLAXOSMITHKLINE LLC | Discontinued | 27 Nov 1989 |
| PROPAFENONE HYDROCHLORIDE | 150MG; 225MG | tablet · oral | WATSON LABS | Discontinued | 24 Oct 2000 |
| PROPAFENONE HYDROCHLORIDE | 150MG; 225MG; 300MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 29 Nov 2001 |
| PROPAFENONE HYDROCHLORIDE | 150MG; 225MG; 300MG | tablet · oral | NESHER PHARMS | Discontinued | 7 Feb 2002 |
| RYTHMOL SR | 225MG; 325MG; 425MG | capsule, extended release · oral | GLAXOSMITHKLINE LLC | Discontinued | 4 Sep 2003 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | MYLAN | Discontinued | 29 Apr 2016 |
| PROPAFENONE HYDROCHLORIDE | 225MG; 325MG; 425MG | capsule, extended release · oral | TWI PHARMS | Discontinued | 18 Jun 2020 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-PROPAFENONE | 02243324 | 150 MG | TABLET · ORAL | APOTEX INC |
| APO-PROPAFENONE | 02243325 | 300 MG | TABLET · ORAL | APOTEX INC |
| MYLAN-PROPAFENONE | 02457164 | 300 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| MYLAN-PROPAFENONE | 02457172 | 150 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| RYTHMOL | 00603708 | 150 MG | TABLET · ORAL | BGP PHARMA ULC |
| RYTHMOL | 00603716 | 300 MG | TABLET · ORAL | BGP PHARMA ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PROPAFENONE HCL 150 MG TABLET | $0.11485 | per EA | 23 Sep 2026 |
| US NADAC | PROPAFENONE HCL 225 MG TAB | $0.20657 | per EA | 23 Sep 2026 |
| US NADAC | PROPAFENONE HCL 300 MG TAB | $0.38802 | per EA | 23 Sep 2026 |
| US NADAC | PROPAFENONE HCL ER 225 MG CAP | $0.29932 | per EA | 23 Sep 2026 |
| US NADAC | PROPAFENONE HCL ER 325 MG CAP | $0.57113 | per EA | 23 Sep 2026 |
| US NADAC | PROPAFENONE HCL ER 425 MG CAP | $0.57777 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Propafenone 150mg tablets | £10.07 | 90 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Propafenone 300mg tablets | £9.34 | 60 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 2 Nov 2018 RYTHMOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Nov 2018 RYTHMOL SR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.