Active ingredient
Lithium Citrate
7 finished FDA listings contain Lithium Citrate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LITHIUM CITRATE
- Dosage forms
- Solution
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 8 meq/5ml
- Brand names in FDA listings
- Lithium
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 52105
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 |
|---|---|---|---|
| ANDA 070755 | PAI HOLDINGS PHARM | 1986-05-21 | 2 |
| ANDA 218036 | RUBICON RESEARCH | 2023-08-14 | 4 |
| ANDA 217183 | SCIEGEN PHARMS | 2024-03-18 | 1 |
Official labeling on DailyMed
- LITHIUM SOLUTION [REMEDYREPACK INC.] · version 4 · 2026-09-02
- LITHIUM SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 1 · 2026-08-26
- LITHIUM SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 7 · 2026-07-17
- LITHIUM (LITHIUM CITRATE) SOLUTION [PRECISION DOSE, INC.] · version 1 · 2025-11-17
- LITHIUM SOLUTION [SAPTALIS PHARMACEUTICALS, LLC] · version 4 · 2025-08-22
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.