Medicine
Lithium citrate 8 mEq/5 mL oral solution
Lithium citrate 8 mEq/5 mL oral solution is a generic prescription medicine for oral use, made by 6 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 citrate
- Brand
- Sold under the generic name
- Strength
- 8 mEq/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 500 mL, 3 trays, 473 mL and 6 more
- Manufacturers
- PAI PharmaRemedyrepackSaptalis PharmaceuticalsAdvagen PharmaAtlantic BiologicalsPrecision Dose
- 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).
- 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
- 9 November 2022
- Identifiers
- RxCUI 756059DailyMed set ID 59d0e8e3-bc0b-0cc1-e063-6394a90a0a6d, e95036c7-542a-437a-969b-f95f6f949f84, 677b20c4-84f0-4716-aca3-aead3bbe1283 +3NDC 17856-1172, 71656-072, 0121-4027 +4Application ANDA218036, ANDA217183, ANDA070755
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 |
|---|---|---|---|
| 500 mL in 1 bottle | 0121-1027-16 | PAI Pharma | 14 April 2026 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4027-94 | PAI Pharma | 14 April 2026 |
| 500 mL in 1 bottle | 72888-172-46 | Advagen Pharma | 14 August 2023 |
| 473 mL in 1 bottle | 71656-072-16 | Saptalis Pharmaceuticals | 5 April 2024 |
| 5 tray in 1 case / 10 cup in 1 tray / 5 mL in 1 cup | 71656-072-50 | Saptalis Pharmaceuticals | 28 March 2024 |
| 30 syringe in 1 case / 15 mL in 1 syringe | 17856-1172-1 | Atlantic Biologicals | 24 August 2026 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 68094-077-62 | Precision Dose | 24 October 2025 |
| 10 cup in 1 box / 5 mL in 1 cup | 70518-4227-0 | Remedyrepack | 4 November 2024 |
| 10 cup, unit-dose in 1 box / 10 mL in 1 cup, unit-dose | 70518-4227-2 | Remedyrepack | 5 November 2024 |
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 23 December 1980 | 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
Clinical summary
Lithium citrate is a mood stabilizer indicated as monotherapy for the treatment of bipolar I disorder. It is available as oral solution. MedsAcross supplies Lithium citrate 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 citrateFor 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 prescribing information (Advagen Pharma) · U.S. National Library of Medicine, DailyMed
Need Lithium citrate 8 mEq/5 mL oral solution 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.