Prescription drug · ANDA
Lacosamide NDC 16714-549
Lacosamide 100 mg/1 · Tablet · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-549-01 | 1671405490116714054901 | 60 TABLET in 1 BOTTLE (16714-549-01)Marketed from Aug 1, 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
- Route
- Oral
- Labeler
- NorthStar RxLLCNDC labeler code 16714
- 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 16714-549_ad8753cb-70b7-431e-9d52-93558d469ef5SPL ID ad8753cb-70b7-431e-9d52-93558d469ef5SPL set ID 9dffda6c-9e44-478f-9e02-9da3ab4c50e1RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0316714548012, 0316714550015, 0316714552019, 0316714549019
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
N416714054901followed by a unit qualifier and the quantityPackage 16714-0549-01. 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 1 month of age and older (1.1) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 1 month of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are 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.
About NDC 16714-549
- What is NDC 16714-549?
- 16714-549 is the product NDC for Lacosamide, Lacosamide 100 mg/1 tablet, listed with the FDA by NorthStar RxLLC. 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?
- NorthStar RxLLC, NDC labeler code 16714. 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 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 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 |