Regulatory PathRegulatory requirements compared

Active substance

Lithium carbonate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Licarb300 mgCapsule · Oral use100 BlisterSAR 100.00Generic · PrescriptionSaudi AmaroxValid
Indications — CHI Daman Drug Formulary

ACUTE MANIA; DEPRESSION

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

ProductStrengthForm · routeApplicantStatusFirst approved
LITHOBID300MGtablet, extended release · oralANI PHARMSPrescription27 Apr 1979
LITHIUM CARBONATE300MG; 150MG; 600MGcapsule · oralHIKMA PHARMSPrescription26 Nov 1980
LITHIUM CARBONATE300MGtablet · oralHIKMA PHARMSPrescription29 Jan 1982
LITHIUM CARBONATE450MGtablet, extended release · oralHIKMA PHARMSPrescription5 Jan 2004
LITHIUM CARBONATE300MGtablet, extended release · oralHIKMA PHARMSPrescription28 Oct 2004
LITHIUM CARBONATE150MG; 300MG; 600MGcapsule · oralALEMBIC LTDPrescription12 Jan 2009
LITHIUM CARBONATE150MG; 300MG; 600MGcapsule · oralGLENMARK PHARMS LTDPrescription3 Feb 2009
LITHIUM CARBONATE150MG; 300MG; 600MGcapsule · oralHETERO LABS LTD IIIPrescription25 Sep 2009
LITHIUM CARBONATE300MGtablet, extended release · oralGLENMARK PHARMSPrescription27 Dec 2010
LITHIUM CARBONATE450MGtablet, extended release · oralGLENMARK PHARMS LTDPrescription14 Feb 2011
LITHIUM CARBONATE300MGtablet, extended release · oralUNIQUEPrescription27 Jul 2015
LITHIUM CARBONATE300MGtablet, extended release · oralHERITAGE PHARMAPrescription29 Sep 2016
LITHIUM CARBONATE450MGtablet, extended release · oralUNIQUEPrescription5 Jun 2017
LITHONATE300MGcapsule · oralSOLVAYDiscontinued6 Apr 1970
LITHIUM CARBONATE300MGtablet · oralPFIZERDiscontinued6 Apr 1970
ESKALITH300MGcapsule · oralNOVEN THERAPDiscontinued6 Apr 1970
LITHOTABS300MGtablet · oralSOLVAYDiscontinued24 Apr 1972
ESKALITH300MGtablet · oralJDS PHARMSDiscontinued26 Feb 1979
ESKALITH CR450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, extended release · oralJDS PHARMSDiscontinued29 Mar 1982
LITHANE300MGtablet · oralBAYER PHARMSDiscontinued18 Jul 1985
LITHIUM CARBONATE300MGcapsule · oralABLEDiscontinued27 Sep 2001
LITHIUM CARBONATE300MGtablet, extended release · oralHERITAGE PHARMADiscontinued10 Jun 2002
LITHIUM CARBONATE300MG; 150MGcapsule · oralPHARMOBEDIENTDiscontinued27 Jun 2002
LITHIUM CARBONATE300MGtablet, extended release · oralABLEDiscontinued21 Apr 2003
LITHIUM CARBONATE450MGtablet, extended release · oralHIKMA INTL PHARMSDiscontinued17 Jun 2003

11 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-LITHIUM CARBONATE02242837150 MGCAPSULE · ORALAPOTEX INC
CARBOLITH00461733150 MGCAPSULE · ORALBAUSCH HEALTH, CANADA INC.
CARBOLITH02011239600 MGCAPSULE · ORALBAUSCH HEALTH, CANADA INC.
LITHANE00406775300 MGCAPSULE · ORALSEARCHLIGHT PHARMA INC
LITHANE02013231150 MGCAPSULE · ORALSEARCHLIGHT PHARMA INC
LITHMAX02266695300 MGTABLET (EXTENDED-RELEASE) · ORALAA PHARMA INC
PMS-LITHIUM CARBONATE - CAP 150MG02216132150 MGCAPSULE · ORALPHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLITHIUM CARBONATE 150 MG CAP$0.09634per EA23 Sep 2026
US NADACLITHIUM CARBONATE 300 MG CAP$0.10387per EA23 Sep 2026
US NADACLITHIUM CARBONATE 300 MG TAB$0.19092per EA23 Sep 2026
US NADACLITHIUM CARBONATE 600 MG CAP$0.24258per EA23 Sep 2026
US NADACLITHIUM CARBONATE ER 300 MG TB$0.1963per EA23 Sep 2026
US NADACLITHIUM CARBONATE ER 450 MG TB$0.25902per EA23 Sep 2026
US NADACLITHOBID ER 300 MG TABLET$12.01942per EA23 Sep 2026
NHS Drug TariffLithium carbonate 200mg modified-release tablets£16.42100 tablet1 Oct 2026
NHS Drug TariffLithium carbonate 250mg tablets£99.53100 tablet1 Oct 2026
NHS Drug TariffLithium carbonate 400mg modified-release tablets£18.60100 tablet1 Oct 2026
NHS Drug TariffLithium carbonate 450mg modified-release tablets£11.8460 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)

  • 24.2.2. Medicines for bipolar disorders · core
    Bipolar or related disorders
    Oral > Solid: 300 mg

Safety signals and safety-related labeling changes

All safety entries for lithium carbonate →

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.