Prescription drug · ANDA
Lithium Carbonate NDC 0615-8480
Lithium carbonate 300 mg/1 · Capsule · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8480-39 | 00615848039 | 30 CAPSULE in 1 BLISTER PACK (0615-8480-39)Marketed from Aug 21, 2023 |
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
- Capsule
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079139
- Marketing start
- Listing expires
- Identifiers
- Product ID 0615-8480_01fffc2d-591d-4a52-b659-7837eabd163aSPL ID 01fffc2d-591d-4a52-b659-7837eabd163aSPL set ID 204d94de-83e4-400e-bd6b-70b49813802cRxCUI 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
N400615848039followed by a unit qualifier and the quantityPackage 00615-8480-39. 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 0615-8480
- What is NDC 0615-8480?
- 0615-8480 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 079139
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 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3565 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-220 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | American Health Packaging | 60687-806 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0668 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1006 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-0547 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2312 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-221 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-220 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-222 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | American Health Packaging | 60687-964 |