Prescription drug · ANDA
Lithium Carbonate NDC 67046-1575
Lithium carbonate 300 mg/1 · Tablet, Film coated, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1575-3 | 67046157503 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3)Marketed from Sep 4, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated, Extended release
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091544
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1575_3dfedfb7-e561-bc6d-e063-6294a90ac562SPL ID 3dfedfb7-e561-bc6d-e063-6294a90ac562SPL set ID 3dfeeb11-a096-ae17-e063-6294a90a9aaeRxCUI 197891UNII 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
N467046157503followed by a unit qualifier and the quantityPackage 67046-1575-03. 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 Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are 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.…
Excerpt only. Read the full label for complete information.
About NDC 67046-1575
- What is NDC 67046-1575?
- 67046-1575 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 tablet, film coated, extended release, listed with the FDA by Coupler LLC. 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?
- Coupler LLC, NDC labeler code 67046. 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 600 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0891 | 00054-0891-25 |
| 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 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 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 ANDA 091544
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 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-223 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-1470 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-3875 |