Prescription drug · NDA
Lithium Carbonate NDC 0054-0886
Lithium carbonate 300 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0886-25 | 0005408862500054088625 | 100 TABLET in 1 BOTTLE (0054-0886-25)Marketed from Aug 16, 2026 | |
| 0054-0886-31 | 0005408863100054088631 | 1000 TABLET in 1 BOTTLE (0054-0886-31)Marketed from Aug 16, 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 Carbonate
- Generic name (nonproprietary)
- lithium carbonate
- Active ingredients
- Lithium carbonate — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018558
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-0886_e89451be-87c9-43df-b41f-b028e56e2c2fSPL ID e89451be-87c9-43df-b41f-b028e56e2c2fSPL set ID b839ff4b-f62d-41ab-a823-550a756d58ecRxCUI 197889, 197890, 197893, 311355UNII 2BMD2GNA4VUPC 0300540887254, 0300540891251, 0300540886257, 0300540890254
- 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
N400054088625followed by a unit qualifier and the quantityPackage 00054-0886-25. 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.
About NDC 0054-0886
- What is NDC 0054-0886?
- 0054-0886 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lithium Carbonate.
- What is the active ingredient?
- Lithium carbonate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 Carbonate?
- 61 other product NDCs are listed under this name. See all Lithium Carbonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lithium Carbonate 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 Carbonate | Lithium carbonate 150 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0887 | 00054-0887-25 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0890 | 00054-0890-2500054-0890-31 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0891 | 00054-0891-25 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-1690 | 67046-1690-03 |
| Lithium Carbonate | Lithium carbonate 450 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4678 | 70518-4678-00 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | American Health Packaging | 60687-964 | 60687-0964-21 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-0547 | 67046-0547-03 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4627 | 70518-4627-00 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-1575 | 67046-1575-03 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-220 | 83209-0220-0683209-0220-1583209-0220-20+2 more |
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. | 0054-4527 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-8528 |
| 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 |