Zanubrutinib Capsule
NDC Package 72579-900-06

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.

Zanubrutinib capsules is a drug for further processing. This formulation utilizes a capsule delivery system. Marketed by Beone Medicines Usa, Inc., this product is identified by NDC 72579-900.

Identification & Billing

NDC Package Code
72579-900-06
Package Description
1 BAG in 1 DRUM / 19000 CAPSULE in 1 BAG
Product Code
72579-900
11-Digit Billing Format
72579090006

Clinical Specifications

Proprietary Name
Zanubrutinib
Non-Proprietary Name
Zanubrutinib
Substance Name
Zanubrutinib
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)
ZANUBRUTINIB 80 mg/1

Regulatory & Marketing

Labeler Name
Beone Medicines Usa, Inc.
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
10-26-2023
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 (72579-900). Click a package code to view its specific billing and regulatory data.

72579-900-01
1 BAG in 1 DRUM / 20223 CAPSULE in 1 BAG
72579-900-02
1 BAG in 1 DRUM / 19900 CAPSULE in 1 BAG
72579-900-03
1 BAG in 1 DRUM / 19600 CAPSULE in 1 BAG
72579-900-04
1 BAG in 1 DRUM / 19400 CAPSULE in 1 BAG
72579-900-05
1 BAG in 1 DRUM / 19200 CAPSULE in 1 BAG
72579-900-07
1 BAG in 1 DRUM / 18800 CAPSULE in 1 BAG

* 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 72579-900-06 identifies a specific commercial package of 1 bag in 1 drum / 19000 capsule in 1 bag of Zanubrutinib (UNFINISHED drug), drug for further processing labeled by Beone Medicines Usa, Inc.. This capsule is formulated for use and contains zanubrutinib 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 Beone Medicines Usa, Inc. on October 26, 2023. The current certification is valid through December 31, 2026.

How is this Beone Medicines Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72579090006. 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)
72579-900-06
11-Digit CMS (5-4-2)
72579-0900-06

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