Lacosamide Tablet, Film Coated
NDC Package 69367-348-60

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

Package Information

Lacosamide tablets is lacosamide is used to prevent and control seizures. This formulation utilizes a tablet, film coated delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-348 and is authorized under FDA application ANDA205237.

Identification & Billing

NDC Package Code
69367-348-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
69367-348
11-Digit Billing Format
69367034860
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lacosamide
Non-Proprietary Name
Lacosamide
Substance Name
Lacosamide
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LACOSAMIDE 50 mg/1
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
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA205237
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-10-2023
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69367-348-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle, plastic of Lacosamide, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This tablet, film coated 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 Westminster Pharmaceuticals, Llc on July 10, 2023. The current certification is valid through December 31, 2027.

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 Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367034860. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
69367-348-60
11-Digit CMS (5-4-2)
69367-0348-60

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