Xcopri Kit
NDC Package 71699-201-28

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

Package Information

Xcopri (cenobamate) kits is xCOPRI is indicated for the treatment of partial-onset seizures in adult patients. This formulation utilizes a kit delivery system. Marketed by Sk Life Science, Inc., this product is identified by NDC 71699-201 and is authorized under FDA application NDA212839.

Identification & Billing

NDC Package Code
71699-201-28
Package Description
1 KIT in 1 CARTON * 1 TABLET in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
71699-201
11-Digit Billing Format
71699020128
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xcopri Titration Pack
Non-Proprietary Name
Cenobamate
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

Regulatory & Marketing

Labeler Name
Sk Life Science, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212839
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-12-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71699-201-28 identifies a specific commercial package of 1 kit in 1 carton * 1 tablet in 1 blister pack * 1 tablet, film coated in 1 blister pack of Xcopri Titration Pack, a human prescription drug labeled by Sk Life Science, Inc.. This kit is formulated for oral use and contains 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 Sk Life Science, Inc. on March 12, 2020. The current certification is valid through December 31, 2026.

How is this Sk Life Science, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71699020128. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
71699-201-28
11-Digit CMS (5-4-2)
71699-0201-28

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