Prescription drug · ANDA
Lacosamide NDC 67877-736
Lacosamide 200 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-736-05 | 67877073605 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-736-05)Marketed from Apr 1, 2022 | |
| 67877-736-31 | 67877073631 | 6 BLISTER PACK in 1 CARTON (67877-736-31) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2022 | |
| 67877-736-60 | 67877073660 | 60 TABLET, FILM COATED in 1 BOTTLE (67877-736-60)Marketed from Apr 1, 2022 | |
| 67877-736-90 | 67877073690 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-736-90)Marketed from Apr 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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- 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 67877-736_062a789f-52f0-482b-9ec0-2ba3ac1572ecSPL ID 062a789f-52f0-482b-9ec0-2ba3ac1572ecSPL set ID 9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7deRxCUI 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
N467877073605followed by a unit qualifier and the quantityPackage 67877-0736-05. 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 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7245 |
| 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 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 |