Prescription drug · ANDA
Lithium NDC 0121-4027
Lithium citrate 8 meq/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-4027-94 | 00121402794 | 3 TRAY in 1 CASE (0121-4027-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4027-05)Marketed from Apr 14, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lithium
- Generic name (nonproprietary)
- lithium
- Active ingredients
- Lithium citrate — 8 meq/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070755
- Marketing start
- Listing expires
- Identifiers
- Product ID 0121-4027_0a44f05f-6cf7-4264-a228-1372bf0e9154SPL ID 0a44f05f-6cf7-4264-a228-1372bf0e9154SPL set ID 677b20c4-84f0-4716-aca3-aead3bbe1283RxCUI 756059UNII 5Z6E9K79YV
- Pharmacologic class
- Mood Stabilizer
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400121402794followed by a unit qualifier and the quantityPackage 00121-4027-94. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) Maintenance treatment in patients 7 years and older ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0121-4027
- What is NDC 0121-4027?
- 0121-4027 is the product NDC for Lithium, Lithium citrate 8 meq/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lithium.
- What is the active ingredient?
- Lithium citrate.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lithium?
- 7 other product NDCs are listed under this name. See all Lithium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lithium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1027 | 00121-1027-16 |
| Lithiumlithium citrate | Lithium citrate 8 meq/5mL | SolutionOral | Precision Dose, Inc. | 68094-077 | 68094-0077-62 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | REMEDYREPACK INC. | 70518-4227 | 70518-4227-0070518-4227-02 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Saptalis Pharmaceuticals, LLC | 71656-072 | 71656-0072-1671656-0072-50 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Advagen Pharma Ltd | 72888-172 | 72888-0172-46 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Atlantic Biologicals Corp. | 17856-1172 | 17856-1172-01 |
| Lithiumlithium bromatum | Lithium bromide 3 [hp_X]/mL | LiquidOral | Marco Pharma International LLC. | 60986-1019 | 60986-1019-0360986-1019-04 |
Other NDCs under ANDA 070755
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1027 |