Regulatory PathRegulatory requirements compared

Active substance

Heparin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HEPARINOL 1000 IU/ML INJECTION1000 IU/mlSolution for injection · Intravenous, Subcutaneous10 VialSAR 165.60Generic · PrescriptionAIN MEDICARE SDN. BHD.Valid
HEPARINOL 5000 IU/ML INJECTION5000 IU/mlSolution for injection · Intravenous, Subcutaneous10 VialSAR 317.40Generic · PrescriptionAIN MEDICARE SDN. BHD.Valid
HEPSAL AMP 10 UNITS-ML10 IU/mlSolution · Intravenous use1 AmpouleSAR 2.70Biological · PrescriptionWOCKHARDT UK LIMITEDValid
HIKMA HEPARIN 5000 IU/ML5000 IU/mlSolution for injection · Intravenous use10 VialSAR 317.40Biological · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
MONOPARIN 25000 U-ML INJ25000 IU/mlSolution for injection · Intravenous use10 Injection SyringeSAR 6.50Biological · PrescriptionWOCKHARDT UK LIMITEDValid
MULTIPARIN 1000 UNITS-ML INJ1000 IU/mlSolution for injection/concentrate for solution for infusion · Intravenous use10 VialSAR 27.85Biological · PrescriptionWOCKHARDT UK LIMITEDValid
MULTIPARIN 25000 UNITS-ML INJ25000 IU/mlSolution for injection/concentrate for solution for infusion · Intravenous use10 VialSAR 114.00Biological · PrescriptionWOCKHARDT UK LIMITEDValid
MULTIPARIN 5000 UNITS-ML INJ5000 IU/mlSolution for injection/concentrate for solution for infusion · Intravenous use10 VialSAR 63.10Biological · PrescriptionWOCKHARDT UK LIMITEDValid
Vaxcel Heparin Sodium Injection5000 IU/mlSolution for injection · Intravenous, Subcutaneous10 VialSAR 213.45Generic · PrescriptionKotra pharma M Sdn BhdValid
MONOPARIN 1000 U-ML INJ1000 IU/mlSolution for injection · Intravenous use1 AmpouleSAR 1.55Biological · PrescriptionWOCKHARDT UK LIMITEDInvalid · Not Marketed
MONOPARIN 25000 U-ML INJ25000 IU/mlSolution for injection · Intravenous use1 AmpouleSAR 27.85Biological · PrescriptionWOCKHARDT UK LIMITEDInvalid · Not Marketed
MONOPARIN 5000 U-MLINJ5000 IU/mlSolution for injection · Intravenous use1 AmpouleSAR 2.90Biological · PrescriptionWOCKHARDT UK LIMITEDInvalid · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ ANTICOAGULATION FOR PATIENTS UNDERGOING CARDIOPULMONARY BYPASS (CBP) & REVERSAL; ANTIPHOSPHOLIPID SYNDROME; BARIATRIC SURGERY; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIALYSIS; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HIP AND KNEE REPLACEMENT SURGERY; HODGKIN'S LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; MYELOFIBROSIS-ADVERSE REACTION MANAGEMENT; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); POLYCYTHEMIA VERA - THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY EMBOLISM; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); T-CELL LYMPHOMA-RENAL TOXICITY; VENOUS THROMBOEMBOLISM DISEASE (VTE)-PROPHYLAXIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
HEPARIN SODIUM1,000 UNITS/ML; 10,000 UNITS/ML; 20,000 UNITS/MLinjectable · injectionFRESENIUS KABI USAPrescription22 Feb 1972
HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/ML; 10,000 UNITS/MLinjectable · injectionFRESENIUS KABI USAPrescription22 Feb 1972
HEPARIN SODIUM IN PLASTIC CONTAINER1,000 UNITS/ML; 5,000 UNITS/ML; 10,000 UNITS/ML; 20,000 UNITS/MLinjectable · injectionFRESENIUS KABI USAPrescription22 Feb 1972
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%50 UNITS/ML; 100 UNITS/MLinjectable · injectionFRESENIUS KABI USAPrescription22 Feb 1972
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%50 UNITS/ML; 100 UNITS/MLinjectable · injectionFRESENIUS KABI USAPrescription22 Feb 1972
HEPARIN SODIUM1,000 UNITS/ML; 5,000 UNITS/ML; 10,000 UNITS/ML; 5,000 UNITS/0.5MLinjectable · injectionHIKMA PHARMSPrescription22 Mar 1972
HEPARIN SODIUM5,000 UNITS/MLinjectable · injectionFRESENIUS KABI USAPrescription10 Feb 1978
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLinjectable · injectionBAXTER HLTHCAREPrescription28 Apr 1982
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100ML; 2,000 UNITS/1000MLinjectable · injectionBAXTER HLTHCAREPrescription28 Apr 1982
HEPARIN SODIUM5,000 UNITS/MLinjectable · injectionHOSPIRAPrescription28 Apr 1983
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100MLinjectable · injectionHOSPIRAPrescription31 Jan 1984
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100ML; 10,000 UNITS/100MLinjectable · injectionHOSPIRAPrescription31 Jan 1984
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLinjectable · injectionHOSPIRAPrescription31 Jan 1984
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLinjectable · injectionHOSPIRAPrescription31 Jan 1984
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLinjectable · injectionHOSPIRAPrescription27 Mar 1985
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100ML; 5,000 UNITS/100MLinjectable · injectionHOSPIRAPrescription27 Mar 1985
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLinjectable · injectionHOSPIRAPrescription27 Mar 1985
HEPARIN SODIUM PRESERVATIVE FREE10,000 UNITS/MLinjectable · injectionHOSPIRAPrescription4 May 1987
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLinjectable · injectionB BRAUNPrescription20 Jul 1992
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100ML; 10,000 UNITS/100MLinjectable · injectionB BRAUNPrescription20 Jul 1992
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLinjectable · injectionB BRAUNPrescription20 Jul 1992
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLinjectable · injectionB BRAUNPrescription20 Jul 1992
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100ML; 10,000 UNITS/100MLinjectable · injectionB BRAUNPrescription20 Jul 1992
HEPARIN SODIUM1,000 UNITS/ML; 5,000 UNITS/ML; 10,000 UNITS/MLinjectable · injectionHOSPIRA INCPrescription31 Aug 2009
HEPARIN SODIUM1,000 UNITS/ML; 5,000 UNITS/ML; 10,000 UNITS/MLinjectable · injectionSAGENT PHARMSPrescription30 Jun 2010

112 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HEPARIN LEO 100UNIT/ML00727520100 UNIT / MLSOLUTION · EXTRACORPOREALLEO PHARMA INC
HEPARIN LEO INJ 1000UNIT/ML004538111000 UNIT / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSLEO PHARMA INC
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION019907482 UNIT / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
HEPARIN SODIUM INJECTION USP0238232610000 UNIT / MLSOLUTION · SUBCUTANEOUS; INTRAVENOUSPFIZER CANADA ULC
HEPARIN SODIUM INJECTION USP024569585000 UNIT / 0.5 MLSOLUTION · SUBCUTANEOUSSTERINOVA INC.
HEPARIN SODIUM INJECTION USP025484885000 UNIT / 0.5 MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSSTERIMAX INC
HEPARIN SODIUM INJECTION USP (MULTIDOSE VIAL-WITH PRESERVATIVE)023030861000 UNIT / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSSANDOZ CANADA INCORPORATED
HEPARIN SODIUM INJECTION, USP0226430710000 UNIT / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSFRESENIUS KABI CANADA LTD
HEPARIN SODIUM INJECTION, USP022643151000 UNIT / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSFRESENIUS KABI CANADA LTD
HEPARIN SODIUM INJECTION, USP0239245310000 UNIT / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSFRESENIUS KABI CANADA LTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACHEPARIN SOD 10,000 UNIT/ML VL$2.09398per ML23 Sep 2026
US NADACHEPARIN SOD 5,000 UNIT/ML SYRG$3.19142per ML23 Sep 2026
US NADACHEPARIN SOD 5,000 UNIT/ML VIAL$1.1796per ML23 Sep 2026
US NADACHEPARIN SODIUM 10,000 UNIT/ML VIAL$2.09398per ML23 Sep 2026
US NADACHEPARIN SODIUM 5,000 UNIT/0.5 ML SYRINGE$5.8995per ML20 May 2026
US NADACHEPARIN SODIUM 5,000 UNIT/ML VIAL$1.1796per ML23 Sep 2026
NHS Drug TariffHeparin sodium 200units/2ml patency solution ampoules£21.1710 ampoule1 Oct 2026
NHS Drug TariffHeparin sodium 50units/5ml patency solution ampoules£20.2010 ampoule1 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)

  • 10.2. Medicines affecting coagulation · core (EML); complementary (EMLc)
    Acute ischaemic heart disease; Unstable angina; Venous thromboembolism
    Parenteral > General injections > IV: 1000 IU per mL in 1 mL ampoule or vial; 20000 IU per mL in 1 mL ampoule or vial (EML); 5000 IU per mL in 1 mL ampoule or vial

Safety signals and safety-related labeling changes

All safety entries for heparin →

Combinations containing Heparin

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.