Prescription drug · ANDA
Lacosamide NDC 31722-813
Lacosamide 100 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-813-05 | 31722081305 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-813-05)Marketed from Mar 17, 2022 | |
| 31722-813-18 | 31722081318 | 180 TABLET, FILM COATED in 1 BOTTLE (31722-813-18)Marketed from Mar 17, 2022 | |
| 31722-813-32 | 31722081332 | 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-813-32)Marketed from Mar 17, 2022 | |
| 31722-813-60 | 31722081360 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-813-60)Marketed from Mar 17, 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, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204787
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 31722-813_54d629b7-e234-69f1-e063-6294a90ab0e7SPL ID 54d629b7-e234-69f1-e063-6294a90ab0e7SPL set ID c5b91128-f838-4e98-9684-5f477fc7af06RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0331722815604, 0331722813600, 0331722814607, 0331722812603
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
N431722081305followed by a unit qualifier and the quantityPackage 31722-0813-05. 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 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 204787
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 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-812 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-814 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-815 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Clinical Solutions Wholesale, LLC | 58118-8814 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Clinical Solutions Wholesale, LLC | 58118-8812 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Clinical Solutions Wholesale, LLC | 58118-8813 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Clinical Solutions Wholesale, LLC | 58118-8815 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1445 |