Lacosamide Oral Solution
NDC Package 81033-427-18

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lacosamide Oral Solution (lacosamide) solution is lacosamide is used to prevent and control seizures. This formulation utilizes a solution delivery system. Marketed by Kesin Pharmaceutical Corporation, this product is identified by NDC 81033-427 and is authorized under FDA application ANDA219699.

Identification & Billing

NDC Package Code
81033-427-18
Package Description
10 CUP, UNIT-DOSE in 1 CARTON / 20 mL in 1 CUP, UNIT-DOSE (81033-427-20)
Product Code
81033-427
11-Digit Billing Format
81033042718
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lacosamide Oral Solution
Non-Proprietary Name
Lacosamide
Substance Name
Lacosamide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LACOSAMIDE 10 mg/mL
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Usage Information
Lacosamide is used to prevent and control seizures. It is an anticonvulsant or antiepileptic drug. It works by reducing the spread of seizure activity in the brain.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Kesin Pharmaceutical Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA219699
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-05-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81033-427). Click a package code to view its specific billing and regulatory data.

81033-427-14
10 CUP, UNIT-DOSE in 1 CARTON / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05)
81033-427-16
10 CUP, UNIT-DOSE in 1 CARTON / 10 mL in 1 CUP, UNIT-DOSE (81033-427-10)
81033-427-17
10 CUP, UNIT-DOSE in 1 CARTON / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81033-427-18 identifies a specific commercial package of 10 cup, unit-dose in 1 carton / 20 ml in 1 cup, unit-dose (81033-427-20) of Lacosamide Oral Solution, a human prescription drug labeled by Kesin Pharmaceutical Corporation. This solution is formulated for oral use and contains lacosamide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kesin Pharmaceutical Corporation on August 05, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Lacosamide is used to prevent and control seizures. It is an anticonvulsant or antiepileptic drug. It works by reducing the spread of seizure activity in the brain.

How is this Kesin Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033042718. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81033-427-18
11-Digit CMS (5-4-2)
81033-0427-18

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.