Beqalzi Tablet, Film Coated
NDC Package 72579-022-01

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

Beqalzi (sonrotoclax) tablets is bEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.This indication is approved under accelerated approval based on response rate and durability of response. This formulation utilizes a tablet, film coated delivery system. Marketed by Beone Medicines Usa, Inc., this product is identified by NDC 72579-022 and is authorized under FDA application NDA220711.

Identification & Billing

NDC Package Code
72579-022-01
Package Description
1 BLISTER PACK in 1 CARTON / 11 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
72579-022
11-Digit Billing Format
72579002201

Clinical Specifications

Proprietary Name
Beqalzi
Non-Proprietary Name
Sonrotoclax
Substance Name
Sonrotoclax
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SONROTOCLAX 80 mg/1
Usage Information
BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) [see Clinical Studies (14.1)].

Regulatory & Marketing

Labeler Name
Beone Medicines Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA220711
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-31-2026
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 (72579-022). Click a package code to view its specific billing and regulatory data.

72579-022-08
1 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE

* 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 72579-022-01 identifies a specific commercial package of 1 blister pack in 1 carton / 11 tablet, film coated in 1 blister pack of Beqalzi, a human prescription drug labeled by Beone Medicines Usa, Inc.. This tablet, film coated is formulated for oral use and contains sonrotoclax 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 August 31, 2026. The current certification is valid through December 31, 2027.

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: 72579002201. 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)
72579-022-01
11-Digit CMS (5-4-2)
72579-0022-01

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