Lithium Carbonate

Treats bipolar I disorder. Sold as Lithonate, Lithium Carbonate, Eskalith, Lithotabs, Lithobid and 2 more. Every FDA application for this active ingredient: 10 branded and 26 generic.

As of Nov 15, 2026, FDA lists 36 applications for Lithium Carbonate (sold as Lithonate, Lithium Carbonate, Eskalith and others), first approved Apr 6, 1970, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 6, 1970
Applications: 36
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $15.1M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Lithium Carbonate	Part D	$7.3M	+2%	100,631
Lithium Carbonate ER	Part D	$6.8M	+3%	62,924
Lithobid	Part D	$1.0M	-12%	127

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LITHIUM CARBONATE 150 MG CAP: $0.097 per unitGeneric · +13% in a year
LITHIUM CARBONATE 300 MG CAP: $0.113 per unitGeneric · -2% in a year
LITHIUM CARBONATE 300 MG TAB: $0.191 per unitGeneric · +0% in a year
LITHIUM CARBONATE 600 MG CAP: $0.242 per unitGeneric · -1% in a year
LITHIUM CARBONATE ER 300 MG TB: $0.192 per unitGeneric · -4% in a year
LITHIUM CARBONATE ER 450 MG TB: $0.261 per unitGeneric · +4% in a year
LITHOBID ER 300 MG TABLET: $12.04 per unitBrand · 0% in a year

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

treatment of Kleine-Levin syndromeLaboratoires Delbert SAS · designated Aug 6, 2024
Treatment of idiopathic pulmonary fibrosisLispiro LLC · designated Mar 29, 2021

Clinical Trials

75 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Smart Sock for Monitoring Walking and Supporting Physical Activity in Older AdultsWalking Mesh · University of Malaya	Not applicable	Not yet recruiting	Oct 28, 2026
Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma PretreatmentProsthodontics, Dental Adhesives/Restorations Performance · University of Ljubljana, Faculty of Medicine	Not applicable	Recruiting	Oct 15, 2026
Clinical Comparison of Lithium Disilicate and 3D-Printed Resin EndocrownsEndodontically Treated Teeth, Nonvital Teeth · Medipol University	Not applicable	Active, not recruiting	Oct 15, 2026
Clinical Evaluation of 3D-Printed Resin Versus CAD/CAM-Milled Lithium Disilicate Overlay RestorationsCAD/CAM, 3D-printed · Tanta University	Not applicable	Enrolling by invitation	Oct 1, 2026
Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior TeethRoot Canal Treated Posterior Teeth, Endodontically-Treated Teeth · Moataz Mostafa Anwar	Not applicable	Recruiting	Sep 23, 2026
An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar TeethDental Restoration Failures · Yousef Mahmoud Salem	Not applicable	Active, not recruiting	Aug 10, 2026
Examining Lithium's Mechanism in Bipolar DisorderHealthy, Bipolar · Northumbria University	Not applicable	Not yet recruiting	Aug 6, 2026
Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory ModelsBipolar Disorder (BD), Bipolar Disorder (BPD) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Not applicable	Not yet recruiting	Jul 29, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 6, 1970	Lithium CarbonateNDA 16834 · New dosage form	Pfizer	5	Discontinued
Apr 6, 1970	LithonateNDA 16782 · New molecular entity	Solvay	21	Discontinued
Apr 6, 1970	EskalithNDA 16860 · New formulation or manufacturer	Noven Therap	32	Discontinued
Apr 24, 1972	LithotabsNDA 16980 · New formulation or manufacturer	Solvay	15	Discontinued
Feb 26, 1979	EskalithNDA 17971 · New formulation or manufacturer	Jds Pharms	10	Discontinued
Apr 27, 1979	LithobidNDA 18027 · New formulation or manufacturer	Ani Pharms	44	Marketed
Nov 26, 1980	Lithium CarbonateNDA 17812 · New formulation or manufacturer	Hikma	29	Marketed
Jan 29, 1982	Lithium CarbonateNDA 18558	Hikma	17	Marketed
Mar 29, 1982	Eskalith CrNDA 18152 · New formulation or manufacturer	Jds Pharms	14	Discontinued
Jul 18, 1985	LithaneNDA 18833 · New formulation or manufacturer	Bayer Pharms	0	Discontinued
Sep 27, 2001	Lithium CarbonateANDA 76121	Able	0	Discontinued
Jun 10, 2002	Lithium CarbonateANDA 76170	Heritage Pharma	2	Discontinued
Jun 27, 2002	Lithium CarbonateANDA 76243	Pharmobedient	6	Discontinued
Apr 21, 2003	Lithium CarbonateANDA 76382	Able	0	Discontinued
Jun 17, 2003	Lithium CarbonateANDA 76490	Hikma Intl Pharms	6	Discontinued
Aug 21, 2003	Lithium CarbonateANDA 76366	Heritage Pharma	5	Discontinued
Jan 5, 2004	Lithium CarbonateANDA 76691	Hikma	5	Marketed
Jun 29, 2004	Lithium CarbonateANDA 76823	Able	0	Discontinued
Oct 28, 2004	Lithium CarbonateANDA 76832	Hikma	7	Marketed
Nov 22, 2004	Lithium CarbonateANDA 76795	Apotex Inc	6	Discontinued
Apr 15, 2008	Lithium CarbonateANDA 78763	Pharmobedient	4	Discontinued
Jan 12, 2009	Lithium CarbonateANDA 79159	Alembic Ltd	5	Marketed
Feb 3, 2009	Lithium CarbonateANDA 79139	Glenmark Pharms Ltd	8	Marketed
Sep 25, 2009	Lithium CarbonateANDA 90702	Hetero Labs Ltd Iii	4	Marketed
Jun 24, 2010	Lithium CarbonateANDA 91027	Sun Pharm Inds Inc	0	Discontinued
Dec 27, 2010	Lithium CarbonateANDA 91544	Glenmark Pharms	7	Marketed
Dec 28, 2010	Lithium CarbonateANDA 78715	Hikma	1	Discontinued
Feb 14, 2011	Lithium CarbonateANDA 91616	Glenmark Pharms Ltd	4	Marketed
Jun 29, 2012	Lithium CarbonateANDA 202288	Pharmobedient	5	Discontinued
Aug 8, 2012	Lithium CarbonateANDA 202219	Pharmobedient	4	Discontinued
Jun 8, 2015	Lithium CarbonateANDA 204445	Alembic	4	Discontinued
Jul 27, 2015	Lithium CarbonateANDA 204779	Unique	5	Marketed
Sep 29, 2016	Lithium CarbonateANDA 205532	Heritage Pharma	5	Marketed
Jun 5, 2017	Lithium CarbonateANDA 205663	Unique	4	Marketed
—	Lithium CarbonateANDA 70407	Watson Labs	0	Discontinued
—	Lithium CarbonateANDA 72542	Usl Pharma	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA