Prescription drug · NDA
Lithium Carbonate NDC 0054-8528
Lithium carbonate 300 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-8528-25 | 00054852825 | 10 TABLET in 1 BLISTER PACK (0054-8528-25)Marketed from Jun 14, 1982 |
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 Carbonate
- Generic name (nonproprietary)
- lithium carbonate
- Active ingredients
- Lithium carbonate — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018558
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-8528_a9e58e66-6569-4c3b-993f-b4236904296eSPL ID a9e58e66-6569-4c3b-993f-b4236904296eSPL set ID 7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84eRxCUI 197889, 197890, 197893, 311355, 756059UNII 2BMD2GNA4VUPC 0300543527638
- 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
N400054852825followed by a unit qualifier and the quantityPackage 00054-8528-25. 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.
Other NDCs under NDA 018558
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 Carbonate | Lithium carbonate 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0886 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4527 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1481 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-174 |