Medicine
Lithium carbonate 450 mg extended-release tablet
Lithium carbonate 450 mg extended-release tablet is a generic prescription medicine for oral use, made by 5 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Key facts
- Active ingredient (INN)
- Lithium carbonate
- Brand
- Sold under the generic name
- Strength
- 450 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 100 blister pack and 4 more
- Manufacturers
- PD-Rx PharmaceuticalsRemedyrepackAmerican Health PackagingHikma PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
- 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
- 13 January 2004
- Identifiers
- RxCUI 197892DailyMed set ID 5e18d105-662d-4729-aa81-00be7472adde, edfceebd-a3e4-4905-bffe-cdc0b948dcd2, a226a88d-eb57-4c96-afda-939801bca0a9 +3NDC 64980-278, 43063-901, 0054-0020 +3Application ANDA205663, ANDA076691
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, extended release in 1 bottle, plastic | 0054-0020-25 | Hikma Pharmaceuticals | 13 January 2004 |
| 100 tablet, extended release in 1 bottle | 64980-278-01 | Rising Pharma Holdings | 1 March 2018 |
| 30 tablet, extended release in 1 blister pack | 70518-2086-0 | Remedyrepack | 16 May 2019 |
| 30 tablet, extended release in 1 blister pack | 70518-4678-0 | Remedyrepack | 19 June 2026 |
| 100 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack | 68084-655-01 | American Health Packaging | 3 January 2014 |
| 100 tablet, extended release in 1 bottle, plastic | 43063-901-01 | PD-Rx Pharmaceuticals | 25 September 2018 |
| 30 tablet, extended release in 1 bottle, plastic | 43063-901-30 | PD-Rx Pharmaceuticals | 28 July 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 450 mg extended-release 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.