Prescription drug · ANDA
Lacosamide NDC 82804-993
Lacosamide 200 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-993-00 | 82804099300 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-00)Marketed from May 21, 2024 | |
| 82804-993-11 | 82804099311 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-11)Marketed from May 21, 2024 | |
| 82804-993-30 | 82804099330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-30)Marketed from May 21, 2024 | |
| 82804-993-55 | 82804099355 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-55)Marketed from May 21, 2024 | |
| 82804-993-60 | 82804099360 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-60)Marketed from May 21, 2024 | |
| 82804-993-64 | 82804099364 | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-64)Marketed from May 21, 2024 | |
| 82804-993-72 | 82804099372 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-72)Marketed from May 21, 2024 | |
| 82804-993-78 | 82804099378 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-78)Marketed from May 21, 2024 | |
| 82804-993-90 | 82804099390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-90)Marketed from May 21, 2024 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205237
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 82804-993_47ae2f1f-d135-4f4e-acc2-500c1afa7b8bSPL ID 47ae2f1f-d135-4f4e-acc2-500c1afa7b8bSPL set ID 47ae2f1f-d135-4f4e-acc2-500c1afa7b8bRxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0382804993307, 0382804991303, 0382804990306, 0382804992300
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
N482804099300followed by a unit qualifier and the quantityPackage 82804-0993-00. 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 is indicated for: • Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1 ) 1.1 Partial-Onset Seizures Lacosamide is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205237
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 200 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-351 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-348 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-349 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-350 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-990 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-991 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-992 |
| Lacosamide | Lacosamide 150 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-194 |
| Lacosamide | Lacosamide 50 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-192 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-193 |
| Lacosamide | Lacosamide 200 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-195 |
| Lacosamide | Lacosamide 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4562 |