Prescription drug · ANDA
Lithium Carbonate NDC 63187-304
Lithium carbonate 300 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-304-30 | 63187030430 | 30 CAPSULE in 1 BOTTLE (63187-304-30)Marketed from May 2, 2016 | |
| 63187-304-60 | 63187030460 | 60 CAPSULE in 1 BOTTLE (63187-304-60)Marketed from May 2, 2016 | |
| 63187-304-90 | 63187030490 | 90 CAPSULE in 1 BOTTLE (63187-304-90)Marketed from May 2, 2016 |
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 Carbonate
- Generic name (nonproprietary)
- lithium carbonate
- Active ingredients
- Lithium carbonate — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090702
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-304_6f7fdb5a-c752-4386-b3d5-39fca7830707SPL ID 6f7fdb5a-c752-4386-b3d5-39fca7830707SPL set ID d3291474-8ef2-4cd8-aecc-2f550fd6a299RxCUI 197889UNII 2BMD2GNA4V
- 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
N463187030430followed by a unit qualifier and the quantityPackage 63187-0304-30. 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)
INDICATIONS AND USAGE Lithium Carbonate Capsule USP is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium Carbonate Capsule USP is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a …
Excerpt only. Read the full label for complete information.
About NDC 63187-304
- What is NDC 63187-304?
- 63187-304 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 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?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 62 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 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0886 | 00054-0886-2500054-0886-31 |
| 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 |
Other NDCs under ANDA 090702
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 | CapsuleOral | Bryant Ranch Prepack | 71335-0120 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4627 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-1690 |
| lithium carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-557 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-544 |
| lithium carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-545 |
| lithium carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-546 |