Prescription drug · ANDA
Lacosamide NDC 0904-7245
Lacosamide 100 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7245-68 | 00904724568 | 60 BLISTER PACK in 1 CARTON (0904-7245-68) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214695
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0904-7245_4743985f-90f2-4859-b737-3c79bf6793d2SPL ID 4743985f-90f2-4859-b737-3c79bf6793d2SPL set ID c83d2156-4dde-4316-98f1-b3dc751f3eacRxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5
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
N400904724568followed by a unit qualifier and the quantityPackage 00904-7245-68. 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 ) • 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 4 years 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. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) tablets. However, due t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214695
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 | Major Pharmaceuticals | 0904-7246 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-735 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7247 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-733 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-734 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-736 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4689 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0510 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4561 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-676 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-687 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-698 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7244 |