Prescription drug · ANDA
Lacosamide NDC 51991-349
Lacosamide 100 mg/1 · Tablet, Film coated · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-349-05 | 51991034905 | 500 TABLET, FILM COATED in 1 BOTTLE (51991-349-05)Marketed from Mar 18, 2022 | |
| 51991-349-06 | 51991034906 | 60 TABLET, FILM COATED in 1 BOTTLE (51991-349-06)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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204921
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 51991-349_d59d1657-c847-475f-998d-49d186f6697eSPL ID d59d1657-c847-475f-998d-49d186f6697eSPL set ID f7ea3ce6-4ca7-4405-a011-48e7d71360a5RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5
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
N451991034905followed by a unit qualifier and the quantityPackage 51991-0349-05. 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 ) 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204921
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 150 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-350 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-348 |
| lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | MSN LABORATORIES PRIVATE LIMITED | 69539-026 |
| lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | MSN LABORATORIES PRIVATE LIMITED | 69539-025 |
| lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | MSN LABORATORIES PRIVATE LIMITED | 69539-027 |
| lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | MSN LABORATORIES PRIVATE LIMITED | 69539-028 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-721 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-722 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-723 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-724 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-351 |