Prescription drug · ANDA
Lithium (Lithium citrate) NDC 68094-077
Lithium citrate 8 meq/5mL · Solution · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-077-62 | 6809400776268094007762 | 3 TRAY in 1 CASE (68094-077-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-077-59)Marketed from Oct 24, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 citrate
- Active ingredients
- Lithium citrate — 8 meq/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Precision Dose, Inc.NDC labeler code 68094
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218036
- Marketing start
- Listing expires
- Identifiers
- Product ID 68094-077_78d523ef-d924-4154-9b2b-3d5a79a75052SPL ID 78d523ef-d924-4154-9b2b-3d5a79a75052SPL set ID a12d50fb-2c2f-4105-ad17-adbf90d439d4RxCUI 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
N468094007762followed by a unit qualifier and the quantityPackage 68094-0077-62. 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 68094-077
- What is NDC 68094-077?
- 68094-077 is the product NDC for Lithium (lithium citrate), Lithium citrate 8 meq/5mL solution, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lithium (Lithium Citrate).
- What is the active ingredient?
- Lithium citrate.
- Who is the labeler?
- Precision Dose, Inc., NDC labeler code 68094. 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 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4027 | 00121-4027-94 |
| 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 218036
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 | Atlantic Biologicals Corp. | 17856-1172 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | REMEDYREPACK INC. | 70518-4227 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Advagen Pharma Ltd | 72888-172 |