FDA label
What is lithium carbonate used for?
The FDA-approved uses of lithium carbonate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of thos...”
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Lithium Carbonate, capsule
Indications and Usage, quoted from the label by Alembic Pharmaceuticals Limited (ANDA079159). Cross-references to other label sections are left out.
Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
Source: DailyMed label, set id d1800f34-3d67-4b2f-874e-8639b125d853, version 3, effective January 27, 2023. NDC 46708-303, one of 26 listings for this product.
Lithium Carbonate, tablet, extended release
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA204779). Cross-references to other label sections are left out.
Lithium carbonate extended-release tablets is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.
Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
Source: DailyMed label, set id 3418bdb6-12ac-4626-9de5-44987b73ae89, version 7, effective April 24, 2025. NDC 64980-205, one of 15 listings for this product.
Questions
What is lithium carbonate used for?
The FDA label says: “Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of thos...”
What drug class is lithium carbonate?
FDA lists lithium carbonate in the Mood Stabilizer established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Lithium Carbonate
- Is Lithium Carbonate a controlled substance?Federal schedule
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- Generic for LithobidFDA Orange Book
- Mood Stabilizers listFDA drug class
- NDC 0054-0886Lithium Carbonate NDC record
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- NDC 0054-0890Lithium Carbonate NDC record