Prescription drug · ANDA
Lacosamide NDC 50228-195
Lacosamide 200 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-195-10 | 5022801951050228019510 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-195-10)Marketed from Mar 18, 2022 | |
| 50228-195-30 | 5022801953050228019530 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-195-30)Marketed from Mar 18, 2022 | |
| 50228-195-60 | 5022801956050228019560 | 60 TABLET, FILM COATED in 1 BOTTLE (50228-195-60)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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals IncNDC labeler code 50228
- 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 50228-195_6cb2853d-e436-45ae-b28e-4310e1ed4be4SPL ID 6cb2853d-e436-45ae-b28e-4310e1ed4be4
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
N450228019510followed by a unit qualifier and the quantityPackage 50228-0195-10. 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 50228-195
- What is NDC 50228-195?
- 50228-195 is the product NDC for Lacosamide, Lacosamide 200 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals Inc. It has 3 package NDCs, 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?
- ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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 50 mg/1 | TabletOral | AvPAK | 50268-491 | 50268-0491-10 |
| 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. | 70518-4562 | 70518-4562-00 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4561 | 70518-4561-0070518-4561-02 |
| 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 |
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 150 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-350 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-351 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-192 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-193 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-194 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-992 |
| 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 200 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-993 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4562 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-349 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-348 |