Regulatory PathRegulatory requirements compared

Active substance

Calcium gluconate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
1% CALCIUM GLUCONATE intravenous infusion BP1 %Solution for infusion · Intravenous use1 BagSAR 14.50Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
CALCIUM GLUCONATE 10% AMP10 %Solution for injection · Intravenous use20 AmpouleSAR 50.25Generic · PrescriptionB. BRAUNValid
CALCIUM GLUCONATE 10% W-V INJECTION10 %Solution for injection · Intravenous use1 AmpouleSAR 3.70Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
CALCIUM GLUCONATE 10% W-V INJECTION10 %Solution for injection · Intravenous use1 AmpouleSAR 4.40Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
CALCIUM GLUCONATE 10% W-V INJECTION10 %Solution for injection · Intravenous use1 AmpouleSAR 6.00Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; BURN MANAGEMENT; HYPOPARATHYROIDISM; PEDIATRIC B-CELL LYMPHOMA; PRE-ECLAMPSIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
CALCIUM GLUCONATE1GM/10ML (100MG/ML); 5GM/50ML (100MG/ML); 10GM/100ML (100MG/ML)solution · intravenousFRESENIUS KABI USAPrescription15 Jun 2017
CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML); 2GM/100ML (20MG/ML); 1GM/100ML (10MG/ML)solution · intravenousHQ SPCLT PHARMAPrescription29 Oct 2018
CALCIUM GLUCONATE10GM/100ML (100MG/ML)solution · intravenousHQ SPCLT PHARMAPrescription29 Oct 2018
CALCIUM GLUCONATE1GM/10ML (100MG/ML); 5GM/50ML (100MG/ML); 10GM/100ML (100MG/ML)solution · intravenousNIVAGENPrescription14 Oct 2022
CALCIUM GLUCONATE10GM/100ML (100MG/ML)solution · intravenousB BRAUN MEDICALPrescription21 Aug 2023
CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML); 2GM/100ML (20MG/ML)solution · intravenousAMNEALPrescription5 Sep 2023
CALCIUM GLUCONATE5GM/50ML (100MG/ML); 10GM/100ML (100MG/ML)solution · intravenousSOMERSETPrescription19 Oct 2023
CALCIUM GLUCONATE1GM/10ML (100MG/ML); 5GM/50ML (100MG/ML); 10GM/100ML (100MG/ML)solution · intravenousAMNEALPrescription10 May 2024
CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML); 2GM/100ML (20MG/ML)solution · intravenousSAGENTPrescription30 Dec 2025
CALCIUM GLUCONATE1GM/10ML (100MG/ML); 5GM/50ML (100MG/ML); 10GM/100ML (100MG/ML)solution · intravenousCAPLINPrescription4 May 2026
CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML); 2GM/100ML (20MG/ML)solution · intravenousMILLA PHARMSPrescription28 Aug 2026
CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML); 2GM/100ML (20MG/ML)solution · intravenousCIPLAPrescription17 Sep 2026
CALCIUM GLUCONATE IN SODIUM CHLORIDE1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · intravenousFRESENIUS KABI USADiscontinued15 Jun 2017

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
2% CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION0253864420 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
CALCIUM GLUCONATE IN SODIUM CHLORIDE INJECTION0255687120 MG / MLSOLUTION · INTRAVENOUSSTERIMAX INC
CALCIUM GLUCONATE INJECTION USP 10%02555042100 MG / MLSOLUTION · INTRAVENOUSSTERIMAX INC
CALCIUM GLUCONATE INJECTION, USP 10%02141019100 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
CALCIUM GLUCONATE INJECTION, USP 10%02523140100 MG / MLSOLUTION · INTRAVENOUSBAXTER CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffCalcium gluconate 1g effervescent tablets£18.3528 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)

  • 27. Vitamins and minerals · complementary
    Tetany due to acute calcium deficiency
    Parenteral > General injections > IV: 100 mg per mL in 10 mL ampoule
  • 4.2. Antidotes and other substances used in poisonings > Specific · core
    Hypermagnesaemia
    Parenteral > General injections > IV: 100 mg per mL in 10 mL ampoule or vial (10%)

Safety signals and safety-related labeling changes

All safety entries for calcium gluconate →

Combinations containing Calcium gluconate

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.