Lacosamide Powder
NDC Package 52038-005-03

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Lacosamide powders is lacosamide is used to prevent and control seizures. This formulation utilizes a powder delivery system. Marketed by Chieron Active Ingredients Private Limited, this product is identified by NDC 52038-005.

Identification & Billing

NDC Package Code
52038-005-03
Package Description
5 kg in 1 DRUM
Product Code
52038-005
11-Digit Billing Format
52038000503

Clinical Specifications

Proprietary Name
Lacosamide
Non-Proprietary Name
Lacosamide
Substance Name
Lacosamide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LACOSAMIDE 25 kg/25kg
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
Chieron Active Ingredients Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-30-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (52038-005). Click a package code to view its specific billing and regulatory data.

52038-005-01
1 kg in 1 DRUM
52038-005-02
2 kg in 1 DRUM
52038-005-04
10 kg in 1 DRUM
52038-005-05
25 kg in 1 DRUM

* 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 52038-005-03 identifies a specific commercial package of 5 kg in 1 drum of Lacosamide (UNFINISHED drug), a bulk ingredient labeled by Chieron Active Ingredients Private Limited. This powder is formulated for 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 Chieron Active Ingredients Private Limited on April 30, 2019. 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 Chieron Active Ingredients Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52038000503. 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)
52038-005-03
11-Digit CMS (5-4-2)
52038-0005-03

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