Active ingredient
Lithium Carbonate
81 finished FDA listings contain Lithium Carbonate as their only active ingredient; 62 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LITHIUM CARBONATE
- Dosage forms
- Capsule, Capsule, Gelatin Coated, Liquid, Pellet, Tablet, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 24
- Strengths listed
- 1 [hp_m]/1 · 100 [hp_c]/1 · 12 [hp_c]/1 · 12 [hp_x]/ml · 150 mg/1 · 200 [hp_c]/1 · 200 [kp_c]/200[kp_c] · 30 [hp_c]/1 · 30 [hp_c]/30[hp_c] · 300 mg/1 · 450 mg/1 · 500 [hp_c]/1 · 6 [hp_c]/1 · 600 mg/1
- Brand names in FDA listings
- Lithium Carb, Lithium Carbonate Er, Lithium Carbonate Lithium Carbonate, Lithium Carbonicum, Lithobid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42351
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018027 | ANI PHARMS | 1979-04-27 | 1 |
| NDA 017812 | HIKMA | 1980-11-26 | 13 |
| NDA 018558 | HIKMA | 1982-01-29 | 5 |
| ANDA 076691 | HIKMA | 2004-01-05 | 4 |
| ANDA 076832 | HIKMA | 2004-10-28 | 5 |
| ANDA 079159 | ALEMBIC LTD | 2009-01-12 | 6 |
| ANDA 079139 | GLENMARK PHARMS LTD | 2009-02-03 | 12 |
| ANDA 090702 | HETERO LABS LTD III | 2009-09-25 | 8 |
| ANDA 091027 | SUN PHARM INDS INC | 2010-06-24 | 1 |
| ANDA 091544 | GLENMARK PHARMS | 2010-12-27 | 4 |
| ANDA 091616 | GLENMARK PHARMS LTD | 2011-02-14 | 4 |
| ANDA 202288 | PHARMOBEDIENT | 2012-06-29 | 1 |
| ANDA 204445 | ALEMBIC | 2015-06-08 | 2 |
| ANDA 204779 | UNIQUE | 2015-07-27 | 2 |
| ANDA 205532 | HERITAGE PHARMA | 2016-09-29 | 1 |
| ANDA 205663 | UNIQUE | 2017-06-05 | 2 |
Official labeling on DailyMed
- LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2026-09-10
- LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 13 · 2026-08-24
- LITHIUM CARBONATE CAPSULE [COUPLER LLC] · version 1 · 2026-08-05
- LITHIUM CARBONATE CAPSULE [REMEDYREPACK INC.] · version 11 · 2026-07-23
- LITHIUM CARBONATE CAPSULE [REMEDYREPACK INC.] · version 17 · 2026-07-16
- LITHIUM CARBONATE CAPSULE, GELATIN COATED [REMEDYREPACK INC.] · version 15 · 2026-07-07
- LITHIUM CARBONATE TABLET [REMEDYREPACK INC.] · version 10 · 2026-07-07
- LITHIUM CARBONATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 16 · 2026-06-30
- LITHIUM CARBONATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 5 · 2026-06-22
- LITHIUM CARBONATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 1 · 2026-06-22
- LITHIUM CARBONATE CAPSULE, GELATIN COATED [REMEDYREPACK INC.] · version 14 · 2026-06-18
- LITHIUM CARBONATE CAPSULE, GELATIN COATED [CARDINAL HEALTH 107, LLC] · version 13 · 2026-06-15
Showing the 12 most recent of 57 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.