Prescription drug · ANDA
lacosamide NDC 68462-681
Lacosamide 200 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc. USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-681-10 | 68462068110 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-681-10)Marketed from Mar 18, 2022 | |
| 68462-681-30 | 68462068130 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-681-30)Marketed from Mar 18, 2022 | |
| 68462-681-60 | 68462068160 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-681-60)Marketed from Mar 18, 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)
- lacosamide
- Generic name (nonproprietary)
- lacosamide
- Active ingredients
- Lacosamide — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc. USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205006
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68462-681_a496c733-ce38-4566-83f9-0287506f4506SPL ID a496c733-ce38-4566-83f9-0287506f4506SPL set ID df1d2e6a-6129-49c9-b2c1-0fdf73f38b9cRxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0368462681602, 0368462679609, 0368462678602, 0368462680605
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
N468462068110followed by a unit qualifier and the quantityPackage 68462-0681-10. 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 .
Indications (excerpt from the label)
Lacosamide tablets are indicated for: • Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) • Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 68462-681
- What is NDC 68462-681?
- 68462-681 is the product NDC for lacosamide, Lacosamide 200 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc. USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lacosamide.
- What is the active ingredient?
- Lacosamide.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc. USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for lacosamide?
- 146 other product NDCs are listed under this name. See all lacosamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lacosamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lacosamide | Lacosamide 50 mg/1 | TabletOral | AvPAK | 50268-491 | 50268-0491-10 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | AvPAK | 50268-492 | 50268-0492-10 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4689 | 70518-4689-0070518-4689-0270518-4689-03 |
| Lacosamide | Lacosamide 10 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-697 | 68462-0697-30 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4561 | 70518-4561-0070518-4561-02 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4562 | 70518-4562-00 |
| Lacosamide | Lacosamide 10 mg/mL | Injection, SolutionIntravenous | Anthea Pharma Private Limited | 83854-002 | 83854-0002-10 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4503 | 70518-4503-00 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4504 | 70518-4504-0070518-4504-0170518-4504-03 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4505 | 70518-4505-00 |
Other NDCs under ANDA 205006
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 |
|---|---|---|---|---|
| lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-678 |
| lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-679 |
| lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-680 |