Regulatory PathRegulatory requirements compared

Active substance

Isoniazid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ISONIAZID 100MG TABLET100 mgTablet · Oral use100 BlisterSAR 15.70Generic · PrescriptionMacleods Pharmaceuticals Ltd.Valid
ISONIAZID 300MG TABLET300 mgTablet · Oral use100 BlisterSAR 38.20NCE · PrescriptionMacleods Pharmaceuticals Ltd.Valid
I.N.H100 mgTablet · Oral use100 Tablet ContainerSAR 7.25NCE · PrescriptionTHE NILE COMPANY FOR PHARMACEUTICALS AND CHEMICAL IND.Invalid · Not Marketed
RIMIFON 100MG TAB100 mgTablet · Oral use100 Tablet ContainerSAR 18.10NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS; LATENT TUBERCULOSIS; RENAL TRANSPLANT; TUBERCULOSIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
ISONIAZID50MG/5MLsyrup · oralCMP PHARMA INCPrescription10 Nov 1983
ISONIAZID100MG; 300MGtablet · oralOMNIVIUM PHARMSPrescription26 Jun 1997
ISONIAZID50MG/5MLsyrup · oralCHARTWELL RXPrescription21 Jul 1997
ISONIAZID100MG/MLinjectable · injectionSANDOZPrescription5 Jul 2005
ISONIAZID100MG; 300MGtablet · oralTHEPHARMANETWORK LLCPrescription29 Oct 2014
NYDRAZID100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionSANDOZDiscontinued29 Sep 1952
ISONIAZID100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralEPIC PHARMA LLCDiscontinued17 Nov 1952
ISONIAZID100MGtablet · oralSUN PHARM INDUSTRIESDiscontinued13 Nov 1970
ISONIAZID100MGtablet · oralWHITEWORTH TOWN PLSNDiscontinued14 Apr 1971
DOW-ISONIAZID300MGtablet · oralDOW PHARMDiscontinued4 Nov 1971
STANOZIDE100MG; 300MGtablet · oralEVERYLIFEDiscontinued21 Jan 1972
ISONIAZID100MGtablet · oralWATSON LABSDiscontinued3 Feb 1972
ISONIAZID100MG; 300MGtablet · oralHIKMA INTL PHARMSDiscontinued28 Feb 1972
ISONIAZID300MGtablet · oralWATSON LABSDiscontinued28 Feb 1972
ISONIAZID50MGtablet · oralWATSON LABSDiscontinued28 Feb 1972
ISONIAZID100MGtablet · oralMK LABSDiscontinued16 Mar 1972
ISONIAZID100MGtablet · oralGENUS LIFESCIENCESDiscontinued24 Aug 1972
ISONIAZID300MGtablet · oralGENUS LIFESCIENCESDiscontinued24 Aug 1972
ISONIAZID100MGtablet · oralIMPAX LABSDiscontinued1 Aug 1973
ISONIAZID300MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued15 Jan 1974
ISONIAZID100MGtablet · oralNEXGEN PHARMA INCDiscontinued22 Oct 1974
LANIAZID50MG; 100MGtablet · oralCHARTWELL MOLECULARDiscontinued29 Aug 1975
ISONIAZID50MG; 100MGtablet · oralPHOENIX LABS NYDiscontinued18 Dec 1975
ISONIAZID300MGtablet · oralSUN PHARM INDUSTRIESDiscontinued11 May 1976
ISONIAZID100MGtablet · oralPHARMAVITEDiscontinued29 Jul 1976

21 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PDP-ISONIAZID00577790100 MGTABLET · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC
PDP-ISONIAZID00577804300 MGTABLET · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC
PDP-ISONIAZID0057781250 MG / 5 MLSOLUTION · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACISONIAZID 100 MG TABLET$1.73222per EA17 Jun 2026
US NADACISONIAZID 300 MG TABLET$3.40199per EA23 Sep 2026
NHS Drug TariffIsoniazid 100mg tablets£54.3428 tablet1 Oct 2026
NHS Drug TariffIsoniazid 50mg tablets£23.8156 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)

  • 6.2.5. Antituberculosis medicines · core
    Tuberculosis
    Oral > Solid > dispersible tablet: 100 mg (scored) (EMLc) | Oral > Solid > tablet: 100 mg; 300 mg

Safety signals and safety-related labeling changes

All safety entries for isoniazid →

Combinations containing Isoniazid

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.