Prescription drug · ANDA
Lacosamide NDC 50268-491
Lacosamide 50 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-491-10 | 50268049110 | 100 BLISTER PACK in 1 BOX (50268-491-10) / 1 TABLET in 1 BLISTER PACK (50268-491-11)Marketed from Sep 29, 2026 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208308
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50268-491_5ca5b051-08b7-2b4d-e063-6294a90a144bSPL ID 5ca5b051-08b7-2b4d-e063-6294a90a144b
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
N450268049110followed by a unit qualifier and the quantityPackage 50268-0491-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50268-491
- What is NDC 50268-491?
- 50268-491 is the product NDC for Lacosamide, Lacosamide 50 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, 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?
- AvPAK, NDC labeler code 50268. 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 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 |
| Lacosamide | Lacosamide 50 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-076 | 68094-0076-62 |
Other NDCs under ANDA 208308
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 | TabletOral | Indoco Remedies Limited | 14445-129 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | Indoco Remedies Limited | 14445-130 |
| Lacosamide | Lacosamide 150 mg/1 | TabletOral | Indoco Remedies Limited | 14445-131 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | Indoco Remedies Limited | 14445-132 |
| Lacosamide | Lacosamide 50 mg/1 | TabletOral | NorthStar RxLLC | 16714-548 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | NorthStar RxLLC | 16714-549 |
| Lacosamide | Lacosamide 150 mg/1 | TabletOral | NorthStar RxLLC | 16714-550 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | NorthStar RxLLC | 16714-552 |
| Lacosamide | Lacosamide 50 mg/1 | TabletOral | Tris Pharma Inc | 27808-243 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | Tris Pharma Inc | 27808-244 |
| Lacosamide | Lacosamide 150 mg/1 | TabletOral | Tris Pharma Inc | 27808-245 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | Tris Pharma Inc | 27808-246 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | AvPAK | 50268-492 |
| Lacosamide | Lacosamide 50 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-220 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-221 |
| Lacosamide | Lacosamide 150 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-222 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-223 |