Prescription drug · ANDA
Lacosamide NDC 27808-246
Lacosamide 200 mg/1 · Tablet · Oral · Tris Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-246-01 | 2780802460127808024601 | 60 TABLET in 1 BOTTLE (27808-246-01)Marketed from Mar 19, 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
- Route
- Oral
- Labeler
- Tris Pharma IncNDC labeler code 27808
- 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 27808-246_299cd2a3-f5a6-4e6e-8f26-84da23cff30cSPL ID 299cd2a3-f5a6-4e6e-8f26-84da23cff30cSPL set ID 7f37f8b8-07d3-48c4-a0c4-7652b62a1ad9RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0327808244017, 0327808243010, 0327808246011, 0327808245014
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
N427808024601followed by a unit qualifier and the quantityPackage 27808-0246-01. 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 is 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 pediatric information.
Excerpt only. Read the full label for complete information.
About NDC 27808-246
- What is NDC 27808-246?
- 27808-246 is the product NDC for Lacosamide, Lacosamide 200 mg/1 tablet, listed with the FDA by Tris Pharma Inc. 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?
- Tris Pharma Inc, NDC labeler code 27808. 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 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 50 mg/1 | TabletOral | AvPAK | 50268-491 |
| 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 |