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  5. NDC Package Code: 72579-122-01 Brukinsa

NDC Package 72579-122-01 Brukinsa

Zanubrutinib Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
72579-122-01
Package Description:
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
72579-122
Proprietary Name:
Brukinsa
Non-Proprietary Name:
Zanubrutinib
Substance Name:
Zanubrutinib
Usage Information:
BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
11-Digit NDC Billing Format:
72579012201
Product Type:
Human Prescription Drug
Labeler Name:
Beone Medicines Usa, Inc.
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
ZANUBRUTINIB 160 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA218785
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-18-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 72579-122-01?

The NDC Packaged Code 72579-122-01 is assigned to a package of 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle of Brukinsa, a human prescription drug labeled by Beone Medicines Usa, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 72579-122 included in the NDC Directory?

Yes, Brukinsa with product code 72579-122 is active and included in the NDC Directory. The product was first marketed by Beone Medicines Usa, Inc. on August 18, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 72579-122-01?

The 11-digit format is 72579012201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-272579-122-015-4-272579-0122-01