Regulatory PathRegulatory requirements compared

Active substance

Sodium bicarbonate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
5%W/V SODIUM BICARBONATE intravenous infusion B.P5 %Solution for infusion · Intravenous use1 BottleSAR 10.70Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
BASIC BICARBONATE CONCENTRATE 8.125% INF8.125 %Solution · Intravenous use1 BagSAR 35.50Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 650GM POWDER650 gPowder for concentrate for solution for haemodialysis · Parenteral use1 BottleSAR 9.05Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 7.5% I.V SOLUTION7.5 %Solution · Intravenous use1 BottleSAR 5.70Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 7.5% I.V SOLUTION7.5 %Solution · Intravenous use1 BottleSAR 6.85Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 7.5% I.V SOLUTION7.5 %Solution · Intravenous use1 BottleSAR 10.50Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 7.5% I.V SOLUTION7.5 %Solution · Intravenous use1 BottleSAR 5.45Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 8.4% INF.8.4 %Solution for infusion · Intravenous use1 BottleSAR 16.00Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 8.4% INF.8.4 %Solution for infusion · Intravenous use1 BottleSAR 8.00Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
SODIUM BICARBONATE 8.4% INJ.8.4 %Solution for injection · Intravenous use1 Pre-filled syringeSAR 7.85Generic · PrescriptionHOSPIRA INCValid
SODIUM BICARBONATE 8.4% INJ.8.4 %Solution for injection · Intravenous use1 Pre-filled syringeSAR 8.20Generic · PrescriptionHOSPIRA INCValid
SODIUM BICARBONATE 840GM POWDER840 gPowder for concentrate for solution for haemodialysis · Parenteral use1 BottleSAR 9.80Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
BASIC BICARBONATE CONCENTRATE 8.4% INFUS8.4 %Solution · Intravenous use1 BagSAR 37.95Generic · PrescriptionPharmaceutical Solution Industries (PSI)Withdrawn by MAH · Not Marketed
HEMODIALYSIS GRADE SOD.BICARB(3P001)840G840 gConcentrate for solution for haemodialysis · Parenteral use1 BottleSAR 13.10Generic · PrescriptionARABIAN DIAGNOSTIC AND MEDICAL COMPANYWithdrawn by MAH · Not Marketed
HEMODIALYSIS GRADE SOD.BICARB(3P003)650G650 gConcentrate for solution for haemodialysis · Parenteral use1 BottleSAR 10.15Generic · PrescriptionARABIAN DIAGNOSTIC AND MEDICAL COMPANYWithdrawn by MAH · Not Marketed
SOD.BICARBONATE 4.2% INJ4.2 %Solution for injection · Intravenous use1 BottleSAR 20.15Generic · PrescriptionB. BRAUNWithdrawn by MAH · Not Marketed
SODIUM BICARB. SOLUTION CAT.NO 3F-0058.4 %Solution · Intravenous use1 BagSAR 19.30Generic · PrescriptionARABIAN DIAGNOSTIC AND MEDICAL COMPANYWithdrawn by MAH · Not Marketed
SODIUM BICARBONATE 5% INF.5 %Solution for infusion · Intravenous use1 BottleSAR 13.80Generic · PrescriptionPharmaceutical Solution Industries (PSI)Withdrawn by MAH · Not Marketed
SODIUM BICARBONATE 5% INFUSION5 %Solution for injection · Intravenous use1 BagSAR 13.80Generic · PrescriptionHOSPIRA INCWithdrawn by MAH · Not Marketed
SODIUM BICARBONATE 7.5% EMG.SYRINGE7.5 %Solution · Intravenous use1 Pre-filled syringeSAR 34.45Generic · PrescriptionHOSPIRA INCWithdrawn by MAH · Not Marketed
SODIUM BICARBONATE 8.4% INF.8.4 %Solution · Intravenous use1 BottleSAR 8.35Generic · PrescriptionPharmaceutical Solution Industries (PSI)Withdrawn by MAH · Not Marketed
SODIUM BICARBONATE 8.4% INJ8.4 %Solution for injection · Intravenous use10 AmpouleSAR 30.95Generic · PrescriptionB. BRAUNWithdrawn by MAH · Not Marketed
SODIUM BICARBONATE 8.4% INJ8.4 %Solution for injection · Intravenous use1 BottleSAR 21.75Generic · PrescriptionB. BRAUNWithdrawn by MAH · Not Marketed
SODIUM BICARBONATE 8.4% INJ8.4 %Solution for injection · Intravenous use1 BottleSAR 8.85Generic · PrescriptionB. BRAUNWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; BURKITT`S LYMPHOMA-URINE ALKALINIZATION; DIARRHEA; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)-URINE ALKALINIZATION; DISORDERS OF PURINE AND PYRIMIDINE METABOLISM; MANTLE CELL LYMPHOMA-URINE ALKALINIZATION; PEDIATRIC B-CELL LYMPHOMA-HBV PROPHYLAXIS; Septic Shock; T-CELL LYMPHOMA-URINE ALKALINIZATION

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

ProductStrengthForm · routeApplicantStatusFirst approved
SODIUM BICARBONATE2.5MEQ/5ML (0.5MEQ/ML)solution · intravenousHOSPIRAPrescription4 Mar 2016
SODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML); 50MEQ/50ML (1MEQ/ML)solution · intravenousHOSPIRAPrescription6 Mar 2017
SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)solution · intravenousHOSPIRAPrescription6 Mar 2017
SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)solution · intravenousHOSPIRAPrescription7 Mar 2017
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousINTL MEDICATION SYSPrescription19 Sep 2017
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousHOSPIRAPrescription26 Sep 2017
SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML); 44.6MEQ/50ML (0.9MEQ/ML); 10MEQ/10ML (1MEQ/ML); 50MEQ/50ML (1MEQ/ML)solution · intravenousEXELA PHARMAPrescription20 Jun 2019
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousOMNIVIUM PHARMSPrescription15 Jun 2023
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousSTERISCIENCEPrescription28 Jun 2023
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousLONG GROVE PHARMSPrescription27 Feb 2024
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousADAPTISPrescription26 Jun 2025
SODIUM BICARBONATE2.5MEQ/5ML (0.5MEQ/ML); 50MEQ/50ML (1MEQ/ML)solution · intravenousFRESENIUS KABI USAPrescription25 Aug 2025
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousAMNEALPrescription13 Jan 2026
SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML); 10MEQ/10ML (1MEQ/ML); 50MEQ/50ML (1MEQ/ML)solution · intravenousASPIROPrescription15 Apr 2026
SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)solution · intravenousMILLA PHARMSPrescription6 Jul 2026
SODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)solution · intravenousAMNEALPrescription9 Jul 2026
SODIUM BICARBONATE150MEQ/1000ML (0.15MEQ/ML)solution · intravenousBAXTER HLTHCARE CORPPrescription14 Aug 2026
SODIUM BICARBONATE IN PLASTIC CONTAINER44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · intravenousABBOTTDiscontinued3 Jun 1986
SODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML); 50MEQ/50ML (1MEQ/ML)solution · intravenousHOSPIRADiscontinued9 Nov 2005

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BIBAG02325586650 G / BAGPOWDER FOR SOLUTION · HAEMODIALYSISFRESENIUS MEDICAL CARE CANADA INC
BIBAG02487756900 G / BAGPOWDER FOR SOLUTION · HAEMODIALYSISFRESENIUS MEDICAL CARE CANADA INC
BICARBONATE CONCENTRATE B380224893480.7 G / LSOLUTION · HAEMODIALYSISCHIEF MEDICAL SUPPLIES LTD
BICARBONATE CONCENTRATE D170000069162381.3 G / LSOLUTION · HAEMODIALYSISVANTIVE ULC
BICART02403498720 G / CARTRIDGEPOWDER · HAEMODIALYSISVANTIVE ULC
BICART024035011250 G / CARTRIDGEPOWDER · HAEMODIALYSISVANTIVE ULC
HEMACART02325772650 G / CARTRIDGEPOWDER FOR SOLUTION · HAEMODIALYSISCHIEF MEDICAL SUPPLIES LTD
SODIUM BICARBONATE INJECTION USP0026199884 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
SODIUM BICARBONATE INJECTION USP0246758584 MG / MLSOLUTION · INTRAVENOUSOMEGA LABORATORIES LIMITED
SODIUM BICARBONATE INJECTION USP0251622584 MG / MLSOLUTION · INTRAVENOUSJAMP PHARMA CORPORATION
SODIUM BICARBONATE INJECTION USP0254190484 MG / MLSOLUTION · INTRAVENOUSSTERIMAX INC
SODIUM BICARBONATE INJECTION, USP0248663684 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSODIUM BICARBONATE 8.4% VIAL$0.154per ML12 Aug 2026
US NADACSODIUM BICARBONATE 8.4% VIAL$0.15869per ML23 Sep 2026
NHS Drug TariffSodium bicarbonate 420mg/5ml (1mmol/ml) oral solution sugar free£35.82100 ml1 Oct 2026
NHS Drug TariffSodium bicarbonate 420mg/5ml (1mmol/ml) oral solution sugar free£179.28500 ml1 Oct 2026
NHS Drug TariffSodium bicarbonate 500mg capsules£5.4056 capsule1 Oct 2026
NHS Drug TariffSodium bicarbonate 500mg gastro-resistant capsules£18.75100 capsule1 Oct 2026
NHS Drug TariffSodium bicarbonate 8.4% (1mmol/ml) solution for injection 100ml bottles£127.0010 bottle1 Oct 2026
NHS Drug TariffSodium bicarbonate 8.4% (1mmol/ml) solution for injection 10ml ampoules£208.4410 ampoule1 Oct 2026
NHS Drug TariffSodium bicarbonate 8.4% (1mmol/ml) solution for injection 250ml bottles£127.0010 bottle1 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

All safety entries for sodium bicarbonate →

Combinations containing Sodium bicarbonate

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.