Regulatory PathRegulatory requirements compared

Active substance

Lithium citrate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LITAREX. TAB 564mg564 mgTablet · Oral use100 Tablet ContainerSAR 16.45NCE · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
LITHIUM CITRATEEQ 300MG CARBONATE/5MLsyrup · oralPAI HOLDINGS PHARMPrescription21 May 1986
LITHIUM CITRATEEQ 300MG CARBONATE/5MLsyrup · oralRUBICON RESEARCHPrescription14 Aug 2023
LITHIUM CITRATEEQ 300MG CARBONATE/5MLsyrup · oralSCIEGEN PHARMSPrescription18 Mar 2024
LITHIUM CITRATEEQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**syrup · oralHIKMA PHARMSDiscontinued23 Dec 1980
LITHONATEEQ 300MG CARBONATE/5MLsyrup · oralSOLVAYDiscontinued

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffLithium citrate 1.018g/5ml oral solution£17.49150 ml1 Oct 2026
NHS Drug TariffLithium citrate 509mg/5ml oral solution£5.79150 ml1 Oct 2026
NHS Drug TariffLithium citrate 520mg/5ml oral solution sugar free£12.11150 ml1 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

  • US FDA 13 Oct 2022 LITHIUM CITRATE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lithium citrate →

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.