Prescription drug · ANDA
Lacosamide NDC 71921-220
Lacosamide 50 mg/1 · Tablet · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71921-220-06 | 71921022006 | 60 TABLET in 1 BOTTLE (71921-220-06)Marketed from Sep 21, 2023 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 71921-220_85fd1828-d3d9-4b4b-965b-7ed7ef5f5e97SPL ID 85fd1828-d3d9-4b4b-965b-7ed7ef5f5e97SPL set ID 3680c0ff-7f5c-4572-b1eb-4fea96b7fbe2RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0371921221066, 0371921222063, 0371921223060
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
N471921022006followed by a unit qualifier and the quantityPackage 71921-0220-06. 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 4 years 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.
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 150 mg/1 | TabletOral | Tris Pharma Inc | 27808-245 |
| Lacosamide | Lacosamide 50 mg/1 | TabletOral | Tris Pharma Inc | 27808-243 |
| Lacosamide | Lacosamide 100 mg/1 | TabletOral | Tris Pharma Inc | 27808-244 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | Tris Pharma Inc | 27808-246 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | NorthStar RxLLC | 16714-552 |
| 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 100 mg/1 | TabletOral | Indoco Remedies Limited | 14445-130 |
| Lacosamide | Lacosamide 50 mg/1 | TabletOral | Indoco Remedies Limited | 14445-129 |
| Lacosamide | Lacosamide 150 mg/1 | TabletOral | Indoco Remedies Limited | 14445-131 |
| Lacosamide | Lacosamide 200 mg/1 | TabletOral | Indoco Remedies Limited | 14445-132 |
| 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 |