Regulatory PathRegulatory requirements compared

Active substance

Acebutolol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASE; EQ 400MG BASEcapsule · oralANI PHARMSPrescription18 Oct 1995
ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASE; EQ 400MG BASEcapsule · oralAMNEAL PHARMPrescription30 Dec 1999
SECTRALEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralPROMIUS PHARMADiscontinued28 Dec 1984
ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASE; EQ 400MG BASEcapsule · oralPHARMOBEDIENTDiscontinued24 Apr 1995

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-ACEBUTOLOL02147602100 MGTABLET · ORALAPOTEX INC
APO-ACEBUTOLOL02147610200 MGTABLET · ORALAPOTEX INC
APO-ACEBUTOLOL02147629400 MGTABLET · ORALAPOTEX INC
TEVA-ACEBUTOLOL02204517100 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-ACEBUTOLOL02204525200 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-ACEBUTOLOL02204533400 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACACEBUTOLOL 200 MG CAPSULE$0.61477per EA23 Sep 2026
US NADACACEBUTOLOL 400 MG CAPSULE$0.84101per EA23 Sep 2026
NHS Drug TariffAcebutolol 400mg tablets£18.6228 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.