Regulatory PathRegulatory requirements compared

Active substance

Chlortalidone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HYGROTON 50MG TABLETS50 mgTablet · Oral use20 BlisterSAR 17.90NCE · PrescriptionAMDIPHARMAWithdrawn by MAH · Not Marketed
HYGROTON 50MG TABLETS50 mgTablet · Oral use20 BlisterSAR 17.90NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
CHLORTHALIDONE50MG; 25MGtablet · oralMYLANPrescription26 Feb 1981
CHLORTHALIDONE50MG; 25MGtablet · oralSUN PHARM INDUSTRIESPrescription21 Jul 1986
THALITONE15MGtablet · oralCASPER PHARMA LLCPrescription20 Dec 1988
CHLORTHALIDONE25MG; 50MGtablet · oralINGENUS PHARMS LLCPrescription30 Mar 2017
CHLORTHALIDONE25MG; 50MGtablet · oralUMEDICAPrescription24 May 2018
CHLORTHALIDONE25MG; 50MGtablet · oralAPPCOPrescription12 Oct 2018
CHLORTHALIDONE25MG; 50MGtablet · oralCHARTWELL RXPrescription26 Feb 2019
CHLORTHALIDONE25MG; 50MGtablet · oralZYDUS PHARMSPrescription10 May 2019
CHLORTHALIDONE25MG; 50MGtablet · oralAMNEAL PHARMS COPrescription1 Jul 2019
CHLORTHALIDONE25MG; 50MGtablet · oralUNICHEMPrescription6 Aug 2019
CHLORTHALIDONE25MG; 50MGtablet · oralALKEM LABS LTDPrescription11 Feb 2020
CHLORTHALIDONE25MG; 50MGtablet · oralAJANTA PHARMA LTDPrescription27 Nov 2020
CHLORTHALIDONE25MG; 50MGtablet · oralADAPTISPrescription9 Feb 2022
CHLORTHALIDONE50MGtablet · oralPHARMOBEDIENTPrescription24 Feb 2022
CHLORTHALIDONE25MGtablet · oralPHARMOBEDIENTPrescription24 Feb 2022
CHLORTHALIDONE25MG; 50MGtablet · oralMANKIND PHARMAPrescription4 Aug 2022
CHLORTHALIDONE25MG; 50MGtablet · oralALEMBICPrescription26 Aug 2022
CHLORTHALIDONE25MG; 50MGtablet · oralIPCA LABS LTDPrescription12 Nov 2024
HEMICLOR12.5MGtablet · oralPRM PHARMAPrescription17 Mar 2025
CHLORTHALIDONE25MG; 50MGtablet · oralMACLEODS PHARMSPrescription1 Jul 2026
HYGROTON50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralSANOFI AVENTIS USDiscontinued7 Apr 1960
CHLORTHALIDONE25MGtablet · oralMUTUAL PHARMDiscontinued5 Mar 1981
CHLORTHALIDONE50MGtablet · oralMUTUAL PHARMDiscontinued5 Mar 1981
CHLORTHALIDONE25MGtablet · oralABBOTTDiscontinued6 Mar 1981
CHLORTHALIDONE50MGtablet · oralABBOTTDiscontinued6 Mar 1981

40 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-CHLORTHALIDONE0036027950 MGTABLET · ORALAPOTEX INC
JAMP CHLORTHALIDONE0252379512.5 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP CHLORTHALIDONE0252380925 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP CHLORTHALIDONE0252381750 MGTABLET · ORALJAMP PHARMA CORPORATION
MINT-CHLORTHALIDONE0255712612.5 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-CHLORTHALIDONE0255713425 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-CHLORTHALIDONE0255714250 MGTABLET · ORALMINT PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCHLORTHALIDONE 25 MG TABLET$0.07433per EA23 Sep 2026
US NADACCHLORTHALIDONE 50 MG TABLET$0.12175per EA23 Sep 2026
US NADACHEMICLOR 12.5 MG TABLET$0.95713per EA23 Sep 2026
US NADACTHALITONE 15 MG TABLET$3.54226per EA23 Sep 2026
NHS Drug TariffChlortalidone 12.5mg tablets£42.0030 tablet1 Oct 2026
NHS Drug TariffChlortalidone 50mg tablets£16.5730 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.

WHO WHO Model List of Essential Medicines (2025)

  • 12.3. Antihypertensive medicines · core
    Therapeutic equivalent to hydrochlorothiazide for Essential hypertension
  • 12.4. Medicines used in heart failure · core
    Therapeutic equivalent to hydrochlorothiazide for Heart failure

Safety signals and safety-related labeling changes

All safety entries for chlortalidone →

Combinations containing Chlortalidone

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.