Prescription drug · ANDA
Lacosamide NDC 50228-193
Lacosamide 100 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-193-10 | 50228019310 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-193-10)Marketed from Mar 18, 2022 | |
| 50228-193-30 | 50228019330 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-193-30)Marketed from Mar 18, 2022 | |
| 50228-193-60 | 50228019360 | 60 TABLET, FILM COATED in 1 BOTTLE (50228-193-60)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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205237
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50228-193_56788345-3f8e-478c-b73d-216b4d711b57SPL ID 56788345-3f8e-478c-b73d-216b4d711b57SPL set ID f4ffa3ad-1278-4772-9ef8-ed6fdaa47605RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0350228195607, 0350228193603, 0350228194600, 0350228192606
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
N450228019310followed by a unit qualifier and the quantityPackage 50228-0193-10. 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 is 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.
Other NDCs under ANDA 205237
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 200 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-351 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-348 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-349 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-350 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-993 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-990 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-991 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-992 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-194 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-192 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-195 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4562 |