Prescription drug · ANDA
Lacosamide NDC 10135-800
Lacosamide 100 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-800-60 | 10135080060 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-800-60)Marketed from Jul 1, 2025 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218014
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 10135-800_67afbd17-4406-4e18-a302-c0a5829ec903SPL ID 67afbd17-4406-4e18-a302-c0a5829ec903SPL set ID 0a273024-c2d2-4fae-90c3-b2f38a323f24RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0310135800605, 0310135799602, 0310135802609
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
N410135080060followed by a unit qualifier and the quantityPackage 10135-0800-60. 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 4 years 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 tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information . 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide tablet is indicated as adjunctive therapy …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218014
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 | Marlex Pharmaceuticals, Inc | 10135-799 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc | 10135-801 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc | 10135-802 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-009 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-008 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-010 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-011 |