Ozanimod Hydrochloride Capsule
NDC Package 43593-800-01

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

Ozanimod Hydrochloride capsules is a drug for further processing. This formulation utilizes a capsule delivery system. Marketed by Celgene International Sarl, this product is identified by NDC 43593-800.

Identification & Billing

NDC Package Code
43593-800-01
Package Description
28053 CAPSULE in 1 DRUM
Product Code
43593-800
11-Digit Billing Format
43593080001

Clinical Specifications

Proprietary Name
Ozanimod Hydrochloride
Non-Proprietary Name
Ozanimod Hydrochloride
Substance Name
Ozanimod Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s)
OZANIMOD HYDROCHLORIDE .92 mg/1

Regulatory & Marketing

Labeler Name
Celgene International Sarl
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-27-2020
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43593-800-01 identifies a specific commercial package of 28053 capsule in 1 drum of Ozanimod Hydrochloride (UNFINISHED drug), drug for further processing labeled by Celgene International Sarl. This capsule is formulated for use and contains ozanimod hydrochloride 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 International Sarl on March 27, 2020. The current certification is valid through December 31, 2027.

How is this Celgene International Sarl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43593080001. 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)
43593-800-01
11-Digit CMS (5-4-2)
43593-0800-01

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