Prescription drug · ANDA
Lacosamide NDC 70518-4561
Lacosamide 100 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4561-0 | 70518456100 | 30 POUCH in 1 BOX (70518-4561-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4561-1)Marketed from Feb 2, 2026 | |
| 70518-4561-2 | 70518456102 | 50 POUCH in 1 BOX (70518-4561-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4561-1)Marketed from Sep 23, 2026 |
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)
- Lacosamide
- Generic name (nonproprietary)
- lacosamide
- Active ingredients
- Lacosamide — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214695
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70518-4561_5c265183-af06-4583-e063-6294a90a2689SPL ID 5c265183-af06-4583-e063-6294a90a2689
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
N470518456100followed by a unit qualifier and the quantityPackage 70518-4561-00. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 214695
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 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7245 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7246 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-735 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7247 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-733 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-734 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-736 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4689 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0510 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-676 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-687 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-698 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7244 |