Zeposia Kit
NDC Package 59572-810-07

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

Zeposia (ozanimod hydrochloride) kits is zEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This formulation utilizes a kit delivery system. Marketed by Celgene Corporation, this product is identified by NDC 59572-810 and is authorized under FDA application NDA209899.

Identification & Billing

NDC Package Code
59572-810-07
Package Description
1 KIT in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK
Product Code
59572-810
11-Digit Billing Format
59572081007
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zeposia 7-day Starter Pack
Non-Proprietary Name
Ozanimod Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Regulatory & Marketing

Labeler Name
Celgene Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA209899
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-27-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59572-810). Click a package code to view its specific billing and regulatory data.

59572-810-97
1 KIT in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK

* 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 59572-810-07 identifies a specific commercial package of 1 kit in 1 blister pack * 1 capsule in 1 blister pack * 1 capsule in 1 blister pack of Zeposia 7-day Starter Pack, a human prescription drug labeled by Celgene Corporation. This kit is formulated for 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 Celgene Corporation on March 27, 2020. The current certification is valid through December 31, 2027.

How is this Celgene Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59572081007. 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)
59572-810-07
11-Digit CMS (5-4-2)
59572-0810-07

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