Prescription drug · ANDA
Lacosamide NDC 68094-076
Lacosamide 50 mg/5mL · Solution · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-076-62 | 68094007662 | 3 TRAY in 1 CASE (68094-076-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-076-59)Marketed from Sep 22, 2025 |
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 — 50 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Precision Dose, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216461
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68094-076_ecaaaf34-a01b-4160-951b-47f72c4b5d9eSPL ID ecaaaf34-a01b-4160-951b-47f72c4b5d9eSPL set ID fe24b28b-ca15-4dfd-a198-53cdc2c8cb99RxCUI 993856UNII 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
N468094007662followed by a unit qualifier and the quantityPackage 68094-0076-62. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 216461
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 | SolutionOral | Leading Pharma, LLC | 69315-318 |
| Lacosamide | Lacosamide 100 mg/10mL | SolutionOral | Precision Dose, Inc. | 68094-176 |
| Lacosamide | Lacosamide 10 mg/mL | SolutionOral | Kanchan Healthcare Inc | 85742-014 |