Prescription drug · ANDA
Lacosamide Oral Solution (Lacosamide) NDC 81033-427
Lacosamide 10 mg/mL · Solution · Oral · Kesin Pharmaceutical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-427-14 | 81033042714 | 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-14) / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05)Marketed from Aug 5, 2025 | |
| 81033-427-16 | 81033042716 | 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-16) / 10 mL in 1 CUP, UNIT-DOSE (81033-427-10)Marketed from Aug 5, 2025 | |
| 81033-427-17 | 81033042717 | 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-17) / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15)Marketed from Aug 5, 2025 | |
| 81033-427-18 | 81033042718 | 10 CUP, UNIT-DOSE in 1 CARTON (81033-427-18) / 20 mL in 1 CUP, UNIT-DOSE (81033-427-20)Marketed from Aug 5, 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 Oral Solution
- Generic name (nonproprietary)
- lacosamide
- Active ingredients
- Lacosamide — 10 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Kesin Pharmaceutical CorporationNDC labeler code 81033
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219699
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 81033-427_3ba29442-4e8b-c2b2-e063-6294a90a1bbfSPL ID 3ba29442-4e8b-c2b2-e063-6294a90a1bbfSPL set ID 3ba29442-4e8a-c2b2-e063-6294a90a1bbfRxCUI 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
N481033042714followed by a unit qualifier and the quantityPackage 81033-0427-14. 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 oral solution is 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 oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide oral solution is 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.
About NDC 81033-427
- What is NDC 81033-427?
- 81033-427 is the product NDC for Lacosamide Oral Solution (lacosamide), Lacosamide 10 mg/mL solution, listed with the FDA by Kesin Pharmaceutical Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lacosamide Oral Solution (Lacosamide).
- What is the active ingredient?
- Lacosamide.
- Who is the labeler?
- Kesin Pharmaceutical Corporation, NDC labeler code 81033. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lacosamide Oral Solution?
- 7 other product NDCs are listed under this name. See all Lacosamide Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lacosamide Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | AvKARE | 73190-103 | 73190-0103-20 |
| Lacosamide Oral Solutionlacosamide oral | Lacosamide 10 mg/mL | SolutionOral | Florida Pharmaceutical Products, LLC | 71921-411 | 71921-0411-71 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-427 | 82983-0427-31 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Kesin Pharma Corporation | 81033-428 | 81033-0428-02 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-885 | 68999-0885-2368999-0885-24 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Chartwell RX, LLC | 62135-885 | 62135-0885-2262135-0885-2362135-0885-24 |
| Lacosamide Oral Solution | Lacosamide 10 mg/mL | SolutionOral | Ascend Laboratories, LLC | 67877-732 | 67877-0732-9567877-0732-97 |
Other NDCs under ANDA 219699
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 Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Kesin Pharma Corporation | 81033-428 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-427 |
| Lacosamide Oral Solutionlacosamide | Lacosamide 10 mg/mL | SolutionOral | AvKARE | 73190-103 |