Regulatory PathRegulatory requirements compared

Active substance

Betaxolol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BETOPTIC OPTHALMIC SOLUTION 0.5%0.5 %Ophthalmic solution · Ocular use1 Dropper ContainerSAR 11.40NCE · PrescriptionNOVARTIS PHARMA AGValid
KERLONE TAB F.C. 20MG20 mgFilm-coated tablet · Oral use28 BlisterSAR 40.15NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
RIALOL0.5 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 29.10Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

OPEN ANGLE GLUCOMA

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

ProductStrengthForm · routeApplicantStatusFirst approved
BETOPTICEQ 0.5% BASEsolution/drops · ophthalmicSANDOZPrescription30 Aug 1985
BETOPTIC SEQ 0.25% BASEsuspension/drops · ophthalmicNOVARTISPrescription29 Dec 1989
BETAXOLOL HYDROCHLORIDE10MG; 20MGtablet · oralEPIC PHARMAPrescription22 Oct 1999
BETAXOLOL HYDROCHLORIDEEQ 0.5% BASEsolution/drops · ophthalmicEUROFARMAPrescription12 Apr 2001
BETAXOLOL HYDROCHLORIDE10MG; 20MGtablet · oralKVK TECHPrescription27 Jun 2008
BETAXOLOL HYDROCHLORIDEEQ 0.5% BASEsolution/drops · ophthalmicCHARTWELL RXPrescription16 Nov 2009
KERLONE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralSANOFI AVENTIS USDiscontinued27 Oct 1989
BETAXOLOL HYDROCHLORIDEEQ 0.5% BASEsolution/drops · ophthalmicPHARMOBEDIENTDiscontinued30 Jun 2000
BETAXOLOL HYDROCHLORIDEEQ 0.5% BASEsolution/drops · ophthalmicAPOTEX INCDiscontinued28 Sep 2000

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBETAXOLOL 10 MG TABLET$0.59124per EA23 Sep 2026
US NADACBETAXOLOL 20 MG TABLET$0.79502per EA19 Nov 2025
US NADACBETAXOLOL HCL 0.5% EYE DROP$8.96243per ML23 Sep 2026
US NADACBETAXOLOL HCL 0.5% EYE DROP$8.98694per ML23 Sep 2026
US NADACBETOPTIC S 0.25% EYE DROP$42.62424per ML7 Jan 2026
US NADACBETOPTIC S 0.25% EYE DROP$42.87902per ML7 Jan 2026
NHS Drug TariffBetaxolol 0.25% eye drops£2.665 ml1 Oct 2026
NHS Drug TariffBetaxolol 0.25% eye drops 0.25ml unit dose preservative free£13.7750 unit dose1 Oct 2026
NHS Drug TariffBetaxolol 0.5% eye drops£1.905 ml1 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 9 Jun 2021 BETOPTIC S — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for betaxolol →

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.