Medicine
Lithium carbonate 300 mg extended-release tablet
Lithium carbonate 300 mg extended-release tablet is a generic prescription medicine for oral use, made by 10 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30° C (59°…
Key facts
- Active ingredient (INN)
- Lithium carbonate
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 80 tablets, 30 tablets, 100 tablets and 24 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAvet PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaRising Pharma HoldingsPD-Rx PharmaceuticalsRemedyrepackA-S Medication SolutionsHikma PharmaceuticalsAmerican Health PackagingCoupler
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30° C (59° 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
- 28 October 2004
- Identifiers
- RxCUI 197891DailyMed set ID 074e3c3b-3a36-4c66-b0a7-e19f9aac8548, 1b65d27e-5086-4a87-8387-c49f3d060978, 8e950a50-689d-4bf8-87ce-cffd43c6d5c2 +12NDC 23155-763, 68462-223, 46708-148 +11Application ANDA205532, ANDA091544, ANDA204445 +3
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 |
|---|---|---|---|
| 80 tablet, extended release in 1 carton | 46708-148-08 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 30 tablet, extended release in 1 bottle | 46708-148-30 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 100 tablet, extended release in 1 bottle | 46708-148-31 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 1000 tablet, extended release in 1 bottle | 46708-148-91 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 80 tablet, extended release in 1 carton | 62332-148-08 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 30 tablet, extended release in 1 bottle | 62332-148-30 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 100 tablet, extended release in 1 bottle | 62332-148-31 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 1000 tablet, extended release in 1 bottle | 62332-148-91 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 100 tablet, film coated, extended release in 1 bottle | 23155-763-01 | Avet PharmaceuticalsIndia | 20 October 2020 |
| 500 tablet, film coated, extended release in 1 bottle | 23155-763-05 | Avet PharmaceuticalsIndia | 20 October 2020 |
| 100 tablet, film coated, extended release in 1 bottle | 68462-223-01 | Glenmark PharmaceuticalsIndia | 27 December 2010 |
| 100 tablet, extended release in 1 bottle, plastic | 0054-0021-25 | Hikma Pharmaceuticals | 28 October 2004 |
| 500 tablet, extended release in 1 bottle, plastic | 0054-0021-29 | Hikma Pharmaceuticals | 28 October 2004 |
| 100 tablet, extended release in 1 bottle | 64980-205-01 | Rising Pharma Holdings | 23 March 2016 |
| 30 tablet, extended release in 1 bottle | 64980-205-03 | Rising Pharma Holdings | 23 March 2016 |
| 500 tablet, extended release in 1 bottle | 64980-205-05 | Rising Pharma Holdings | 23 March 2016 |
| 90 tablet, extended release in 1 bottle | 64980-205-09 | Rising Pharma Holdings | 23 March 2016 |
| 30 tablet, extended release in 1 blister pack | 70518-0608-0 | Remedyrepack | 6 July 2017 |
| 30 tablet, extended release in 1 blister pack | 70518-3681-1 | Remedyrepack | 19 June 2026 |
| 30 tablet, film coated, extended release in 1 blister pack | 70518-3875-0 | Remedyrepack | 26 September 2023 |
| 60 tablet, film coated, extended release in 1 bottle | 50090-1470-0 | A-S Medication Solutions | 28 November 2014 |
| 60 tablet, film coated, extended release in 1 bottle | 50090-6052-0 | A-S Medication Solutions | 23 August 2022 |
| 100 tablet, extended release in 1 bottle, plastic | 72789-171-01 | PD-Rx Pharmaceuticals | 28 July 2023 |
| 30 tablet, extended release in 1 bottle, plastic | 72789-171-30 | PD-Rx Pharmaceuticals | 4 January 2021 |
| 500 tablet, extended release in 1 bottle, plastic | 72789-171-82 | PD-Rx Pharmaceuticals | 23 August 2023 |
| 100 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack | 68084-640-01 | American Health Packaging | 13 October 2014 |
| 30 tablet, film coated, extended release in 1 blister pack | 67046-1575-3 | Coupler | 4 September 2025 |
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
Alternatives
Other makers and brands of Lithium carbonate 300 mg extended-release tablet.
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 extended-release tablet for your hospital or patient?
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