Prescription drug · ANDA
Lacosamide NDC 72603-263
Lacosamide 10 mg/mL · Injection · Intravenous · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-263-02 | 72603026302 | 10 VIAL, GLASS in 1 CARTON (72603-263-02) / 20 mL in 1 VIAL, GLASS (72603-263-01)Marketed from Jul 15, 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 — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216335
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72603-263_1eee4107-cf4c-987c-e063-6394a90a5d3eSPL ID 1eee4107-cf4c-987c-e063-6394a90a5d3eSPL set ID e969b294-48d9-42a2-a093-0ac715142460RxCUI 809974UNII 563KS2PQY5UPC 0372603263015
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N472603026302followed by a unit qualifier and the quantityPackage 72603-0263-02. 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 17 years of age and older ( 1.1 ) 1.1 Partial-Onset Seizures Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. Pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) injection. 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 216335
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 10 mg/mL | InjectionIntravenous | Camber Pharmaceuticals, Inc. | 31722-203 |
| Lacosamide | Lacosamide 10 mg/mL | InjectionIntravenous | XLCare Pharmaceuticals Inc. | 72865-235 |