Regulatory PathRegulatory requirements compared

Active substance

Flecainide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
TAMBOCOR 100MG TAB100 mgTablet · Oral use60 BlisterSAR 59.05NCE · Prescription3MInvalid · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralAMNEAL PHARMPrescription31 Jul 2001
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralANI PHARMSPrescription28 Oct 2002
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralHIKMA PHARMSPrescription14 Jan 2003
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralSUN PHARM INDS LTDPrescription28 Mar 2003
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralAUROBINDO PHARMA LTDPrescription3 Nov 2017
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralREGCON HOLDINGSPrescription16 Sep 2020
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralYICHANG HUMANWELLPrescription8 Sep 2022
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralMICRO LABSPrescription22 Apr 2026
TAMBOCOR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralALVOGENDiscontinued31 Oct 1985
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralANI PHARMSDiscontinued28 Oct 2002
FLECAINIDE ACETATE50MG; 100MG; 150MGtablet · oralCHARTWELLDiscontinued9 Jul 2009

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-FLECAINIDE0251606350 MGTABLET · ORALANGITA PHARMA INC.
AG-FLECAINIDE02516071100 MGTABLET · ORALANGITA PHARMA INC.
APO-FLECAINIDE0227553850 MGTABLET · ORALAPOTEX INC
APO-FLECAINIDE02275546100 MGTABLET · ORALAPOTEX INC
AURO-FLECAINIDE0245995750 MGTABLET · ORALAURO PHARMA INC
AURO-FLECAINIDE02459965100 MGTABLET · ORALAURO PHARMA INC
FLECAINIDE0253480050 MGTABLET · ORALSANIS HEALTH INC
FLECAINIDE02534819100 MGTABLET · ORALSANIS HEALTH INC
JAMP FLECAINIDE0249370550 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP FLECAINIDE02493713100 MGTABLET · ORALJAMP PHARMA CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFLECAINIDE ACETATE 100 MG TAB$0.17126per EA23 Sep 2026
US NADACFLECAINIDE ACETATE 150 MG TAB$0.26903per EA23 Sep 2026
US NADACFLECAINIDE ACETATE 50 MG TAB$0.10844per EA23 Sep 2026
NHS Drug TariffFlecainide 100mg tablets£4.9660 tablet1 Oct 2026
NHS Drug TariffFlecainide 50mg tablets£2.7360 tablet1 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.

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.