Prescription drug · ANDA
Lithium Carbonate ER (Lithium carbonate) NDC 42291-496
Lithium carbonate 450 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-496-01 | 42291049601 | 100 TABLET in 1 BOTTLE (42291-496-01)Marketed from Feb 25, 2022 |
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 ERSuffix: ER
- Generic name (nonproprietary)
- lithium carbonate
- Active ingredients
- Lithium carbonate — 450 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091616
- Marketing start
- Listing expires
- Identifiers
- Product ID 42291-496_485f83f8-8405-eae8-e063-6294a90a3c33SPL ID 485f83f8-8405-eae8-e063-6294a90a3c33SPL set ID d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0RxCUI 197892UNII 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
N442291049601followed by a unit qualifier and the quantityPackage 42291-0496-01. 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 Extended-Release Tablets are indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. 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 patient experiencing a manic episode, Lithium Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.
Excerpt only. Read the full label for complete information.
About NDC 42291-496
- What is NDC 42291-496?
- 42291-496 is the product NDC for Lithium Carbonate ER (lithium carbonate), Lithium carbonate 450 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lithium Carbonate ER (Lithium Carbonate).
- What is the active ingredient?
- Lithium carbonate.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. 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 ER?
- 3 other product NDCs are listed under this name. See all Lithium Carbonate ER 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 ER 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 ERlithium carbonate | Lithium carbonate 450 mg/1 | TabletOral | Coupler LLC | 67046-0408 | 67046-0408-03 |
| Lithium Carbonate ERlithium carbonate | Lithium carbonate 450 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4589 | 70518-4589-00 |
| Lithium Carbonate ERlithium carbonate | Lithium carbonate 450 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-224 | 68462-0224-0168462-0224-1068462-0224-30 |
Other NDCs under ANDA 091616
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 ERlithium carbonate | Lithium carbonate 450 mg/1 | TabletOral | Coupler LLC | 67046-0408 |
| Lithium Carbonate ERlithium carbonate | Lithium carbonate 450 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-224 |
| Lithium Carbonate ERlithium carbonate | Lithium carbonate 450 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4589 |