Quick answers
- What is Lithium carbonate used for?
- The FDA-approved label (Lithium Carbonate, Hikma Pharmaceuticals USA Inc., August 16, 2026) says: “Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older […] • Maintenance treatment in patients 7 years and older […] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lithium carbonate have a boxed warning?
- Yes. The FDA label for Lithium Carbonate has a boxed warning (“WARNING: LITHIUM TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lithium carbonate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lithium carbonate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lithium carbonate?
- 21 companies list prescription products of Lithium carbonate in the FDA NDC Directory, including Remedyrepack Inc., Hikma Pharmaceuticals USA Inc. and PD-Rx Pharmaceuticals, Inc..
What Lithium carbonate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older […] • Maintenance treatment in patients 7 years and older […] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder …
— FDA label: Lithium Carbonate, Hikma Pharmaceuticals USA Inc., effective August 16, 2026. Read the full label on DailyMed →
The FDA has 48 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: LITHIUM TOXICITY
. Read it on the full label →
48 of 48 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet, extended release · Capsule, gelatin coated · Tablet · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 70 in the FDA NDC Directory |
| Brand names | Lithobid |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lithium carbonate 150 mg capsule | Generic | $0.0972 per capsule |
| lithium carbonate 150 mg capsule, gelatin coated | Generic | $0.0972 per capsule |
| lithium carbonate 300 mg capsule | Generic | $0.1129 per capsule |
| lithium carbonate 300 mg capsule, gelatin coated | Generic | $0.1129 per capsule |
| lithium carbonate 300 mg tablet | Generic | $0.1912 per tablet |
| lithium carbonate 300 mg tablet, extended release | Generic | $0.1924 per tablet |
| lithium carbonate 300 mg tablet, film coated, extended release | Generic | $0.1924 per tablet |
| lithium carbonate 300 mg tablet, film coated, extended release | Brand: Lithobid | $12.04 per tablet |
| lithium carbonate 450 mg tablet | Generic | $0.2612 per tablet |
| lithium carbonate 450 mg tablet, extended release | Generic | $0.2612 per tablet |
| lithium carbonate 600 mg capsule | Generic | $0.2424 per capsule |
| lithium carbonate 600 mg capsule, gelatin coated | Generic | $0.2424 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Remedyrepack Inc.13 products
- Hikma Pharmaceuticals USA Inc.13 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Glenmark Pharmaceuticals Inc., USA5 products
- Alembic Pharmaceuticals Limited4 products
- Alembic Pharmaceuticals Inc.4 products
- Coupler LLC4 products
- American Health Packaging4 products
- Camber Pharmaceuticals, Inc.3 products
- Bryant Ranch Prepack2 products
- Rising Pharma Holdings, Inc.2 products
- A-S Medication Solutions2 products
- AvKARE1 product
- Sun Pharmaceutical Industries, Inc.1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Boswell Pharmacy Services LLC d/b/a BPS Wholesale1 product
- Cardinal Health 107, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- Proficient Rx LP1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017812 LITHIUM CARBONATE | Hikma | November 26, 1980 | 29, latest October 13, 2022 2022: Labeling · 2020: Labeling · 2018: Labeling |
| NDA018027 LITHOBID | Ani Pharms | April 27, 1979 | 44, latest October 13, 2022 2022: Labeling · 2020: Labeling · 2018: Labeling |
| NDA018558 LITHIUM CARBONATE | Hikma | January 29, 1982 | 17, latest October 13, 2022 2022: Labeling · 2022: Labeling · 2020: Labeling |
Generic approvals (13)
- ANDA076691Hikma · January 5, 2004
- ANDA076832Hikma · October 28, 2004
- ANDA079159Alembic Ltd · January 12, 2009
- ANDA079139Glenmark Pharms Ltd · February 3, 2009
- ANDA090702Hetero Labs Ltd III · September 25, 2009
- ANDA091027Sun Pharm Inds Inc · June 24, 2010
- ANDA091544Glenmark Pharms · December 27, 2010
- ANDA091616Glenmark Pharms Ltd · February 14, 2011
- ANDA202288Pharmobedient · June 29, 2012
- ANDA204445Alembic · June 8, 2015
- ANDA204779Unique · July 27, 2015
- ANDA205532Heritage Pharma · September 29, 2016
- ANDA205663Unique · June 5, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lithium Carbonate, Hikma Pharmaceuticals USA Inc., effective August 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →