Regulatory PathRegulatory requirements compared

Active substance

Isosorbide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ISOBIDE40 mgModified-release capsule · Oral use20 BlisterSAR 27.30Generic · PrescriptionRIYADH PHARMAValid
ISOBIDE20 mgModified-release capsule · Oral use20 BlisterSAR 18.85Generic · PrescriptionRIYADH PHARMAValid
IMDUR 60MG DURULES60 mgTablet · Oral use30 BlisterSAR 25.25NCE · PrescriptionAstraZenecaWithdrawn by regulatory authority · Not Marketed
IMDUR 60MG DURULES60 mgTablet · Oral use100 Tablet ContainerSAR 74.85NCE · PrescriptionAstraZenecaWithdrawn by regulatory authority · Not Marketed
ISOKET 0.1% AMPOULE0.1 %Solution · Intravenous use10 AmpouleSAR 72.45NCE · PrescriptionSCHWARTZ PHARMAInvalid · Not Marketed
ISORDIL 10 MG. TABLETS10 mgTablet · Oral use100 Tablet ContainerSAR 16.25NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed
ISORDIL SUBLINGUAL 5 MG. TAB.5 mgTablet · Sublingual use100 Tablet ContainerSAR 16.25NCE · PrescriptionPFIZERWithdrawn by MAH · Not Marketed
WESORBIDE 10MG TAB10 mgTablet · Oral use100 Tablet ContainerSAR 8.80Generic · PrescriptionWEST-WARDWithdrawn by MAH · Not Marketed
WESORBIDE 2.5MG SUBLINGUAL TAB2.5 mgTablet · Sublingual use100 Tablet ContainerSAR 5.20Generic · PrescriptionWEST-WARDWithdrawn by MAH · Not Marketed
WESORBIDE 20MG TAB20 mgTablet · Oral use100 Tablet ContainerSAR 14.45Generic · PrescriptionWEST-WARDWithdrawn by MAH · Not Marketed
WESORBIDE 5MG S-L TAB5 mgTablet · Oral use100 Tablet ContainerSAR 8.80Generic · PrescriptionWEST-WARDWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

CARDIOMYOPATHY; CORONARY ARTERY DISEASE

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

ProductStrengthForm · routeApplicantStatusFirst approved
ISORDIL40MG; 5MGtablet · oralBAUSCHPrescription9 Nov 1959
ISOSORBIDE DINITRATE5MGtablet · oralPH HEALTHPrescription12 Mar 1987
ISOSORBIDE DINITRATE10MGtablet · oralPH HEALTHPrescription12 Mar 1987
ISOSORBIDE DINITRATE30MGtablet · oralPH HEALTHPrescription12 Mar 1987
ISOSORBIDE DINITRATE20MGtablet · oralPH HEALTHPrescription2 Oct 1987
ISOSORBIDE DINITRATE20MG; 10MG; 5MGtablet · oralHIKMA INTL PHARMSPrescription2 Nov 1987
ISOSORBIDE DINITRATE5MGtablet · oralSANDOZPrescription7 Jan 1988
ISOSORBIDE DINITRATE10MGtablet · oralSANDOZPrescription7 Jan 1988
ISOSORBIDE DINITRATE20MGtablet · oralSANDOZPrescription7 Apr 1988
MONOKET20MG; 10MGtablet · oralOMNIVIUM PHARMSPrescription30 Jun 1993
ISOSORBIDE MONONITRATE20MG; 10MGtablet · oralGENUSPrescription30 Oct 1998
ISOSORBIDE MONONITRATE60MG; 30MG; 120MGtablet, extended release · oralCHARTWELL MOLECULARPrescription30 Oct 1998
ISOSORBIDE MONONITRATE20MG; 10MGtablet · oralANI PHARMSPrescription27 Nov 1998
ISOSORBIDE MONONITRATE30MG; 60MG; 120MGtablet, extended release · oralZYDUS HLTHCAREPrescription16 Mar 2000
ISOSORBIDE MONONITRATE60MG; 30MGtablet, extended release · oralDEXCEL LTDPrescription17 Apr 2000
ISOSORBIDE MONONITRATE30MGtablet, extended release · oralTORRENT PHARMSPrescription3 Jun 2011
ISOSORBIDE MONONITRATE60MG; 120MGtablet, extended release · oralTORRENT PHARMSPrescription3 Jun 2011
ISOSORBIDE MONONITRATE120MGtablet, extended release · oralDEXCEL LTDPrescription29 Aug 2018
ISOSORBIDE MONONITRATE30MG; 60MG; 120MGtablet, extended release · oralRICONPHARMA LLCPrescription5 Nov 2018
ISOSORBIDE DINITRATE5MG; 10MG; 20MG; 30MG; 40MGtablet · oralZYDUS LIFESCIENCESPrescription20 Nov 2019
ISOSORBIDE DINITRATE40MGtablet · oralPH HEALTHPrescription23 Nov 2021
ISOSORBIDE MONONITRATE120MG; 30MG; 60MGtablet, extended release · oralSHANDONGPrescription29 Apr 2022
ISOSORBIDE DINITRATE5MG; 10MG; 20MG; 30MG; 40MGtablet · oralRUBICON RESEARCHPrescription8 Jul 2022
ISOSORBIDE MONONITRATE30MG; 60MG; 120MGtablet, extended release · oralAUROBINDO PHARMAPrescription7 Nov 2022
ISORDIL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG **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 · oralBAUSCHDiscontinued9 Nov 1959

42 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ISDN0044168610 MGTABLET · ORALAA PHARMA INC
ISDN0044169430 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACISOSORBIDE DINITRATE 10 MG TAB$0.15421per EA23 Sep 2026
US NADACISOSORBIDE DINITRATE 20 MG TAB$0.19894per EA23 Sep 2026
US NADACISOSORBIDE DINITRATE 30 MG TAB$0.2808per EA23 Sep 2026
US NADACISOSORBIDE DINITRATE 40 MG TAB$3.3103per EA23 Sep 2026
US NADACISOSORBIDE DINITRATE 5 MG TAB$0.17675per EA23 Sep 2026
US NADACISOSORBIDE MONONIT 10 MG TAB$2.40398per EA30 Sep 2026
US NADACISOSORBIDE MONONIT 20 MG TAB$2.29118per EA30 Sep 2026
US NADACISOSORBIDE MONONIT ER 120 MG$0.16621per EA23 Sep 2026
US NADACISOSORBIDE MONONIT ER 30 MG TB$0.06877per EA23 Sep 2026
US NADACISOSORBIDE MONONIT ER 60 MG TB$0.09688per EA23 Sep 2026
NHS Drug TariffIsosorbide dinitrate 10mg tablets£11.7056 tablet1 Oct 2026
NHS Drug TariffIsosorbide dinitrate 20mg modified-release tablets£3.0460 tablet1 Oct 2026
NHS Drug TariffIsosorbide dinitrate 20mg tablets£12.1556 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 10mg tablets£1.7856 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 20mg tablets£3.1956 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 25mg modified-release capsules£5.7928 capsule1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 25mg modified-release tablets£6.7528 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 30mg modified-release tablets£9.1928 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 30mg tablets£7.8956 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 40mg modified-release capsules£6.5228 capsule1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 40mg modified-release tablets£9.1428 tablet1 Oct 2026
NHS Drug TariffIsosorbide mononitrate 40mg tablets£5.4256 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)

  • 12.1. Antianginal medicines · core
    Angina pectoris
    Oral > Solid: 5 mg sublingual tablet

Safety signals and safety-related labeling changes

All safety entries for isosorbide →

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.