Medicine
Lithium carbonate 300 mg tablet
Lithium carbonate 300 mg tablet is a generic prescription medicine for oral use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store and Dispense Store at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Lithium carbonate
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 8 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaHikma PharmaceuticalsPD-Rx PharmaceuticalsRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). NDC 0054-2531-25: Bottle of 100 Capsules Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). PROTECT FROM MOISTURE.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 January 1982
- Identifiers
- RxCUI 197889, 197890, 197893 +2DailyMed set ID 7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e, d3284649-ed4c-4096-987b-4ac16b8278f2, b839ff4b-f62d-41ab-a823-550a756d58ec +2NDC 0054-8528, 62756-430, 0054-0886 +3Application NDA018558, ANDA091027
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 62756-430-08 | Sun Pharmaceutical IndustriesIndia | 8 July 2010 |
| 1000 tablet in 1 bottle | 62756-430-18 | Sun Pharmaceutical IndustriesIndia | 8 July 2010 |
| 30 tablet in 1 bottle | 62756-430-83 | Sun Pharmaceutical IndustriesIndia | 8 July 2010 |
| 100 tablet in 1 bottle | 62756-430-88 | Sun Pharmaceutical IndustriesIndia | 8 July 2010 |
| 100 tablet in 1 bottle | 0054-0886-25 | Hikma Pharmaceuticals | 16 August 2026 |
| 1000 tablet in 1 bottle | 0054-0886-31 | Hikma Pharmaceuticals | 16 August 2026 |
| 100 tablet in 1 bottle | 0054-4527-25 | Hikma Pharmaceuticals | 29 January 1982 |
| 1000 tablet in 1 bottle | 0054-4527-31 | Hikma Pharmaceuticals | 29 January 1982 |
| 10 tablet in 1 blister pack | 0054-8528-25 | Hikma Pharmaceuticals | 14 June 1982 |
| 100 tablet in 1 bottle, plastic | 72789-174-01 | PD-Rx Pharmaceuticals | 9 March 2021 |
| 30 tablet in 1 blister pack | 70518-1481-1 | Remedyrepack | 8 June 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 6 April 1970 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Lithium carbonate
Clinical summary
Lithium carbonate is a mood stabilizer indicated as monotherapy for the treatment of bipolar I disorder, among other approved uses. It is available as capsules, extended-release tablets and tablets for oral use. MedsAcross supplies Lithium carbonate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Lithium carbonateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lithium Carbonate prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Lithium carbonate 300 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.