72579-900 NDC - ZANUBRUTINIB

Drug Information

  • Product NDC: 72579-900
  • Proprietary Name:
  • Non Proprietary Name: zanubrutinib
  • Active Ingredient(s): 80 mg/1 ZANUBRUTINIB
  • Administration Route(s):
  • Dosage Form(s): CAPSULE

Labeler Information

Field Name Field Value
Labeler Name: BeOne Medicines USA, Inc.
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:10/26/2023

Package Information

No. Package Code Package Description Billing Unit
172579-900-011 BAG in 1 DRUM (72579-900-01) / 20223 CAPSULE in 1 BAG
272579-900-021 BAG in 1 DRUM (72579-900-02) / 19900 CAPSULE in 1 BAG
372579-900-031 BAG in 1 DRUM (72579-900-03) / 19600 CAPSULE in 1 BAG
472579-900-041 BAG in 1 DRUM (72579-900-04) / 19400 CAPSULE in 1 BAG
572579-900-051 BAG in 1 DRUM (72579-900-05) / 19200 CAPSULE in 1 BAG
672579-900-061 BAG in 1 DRUM (72579-900-06) / 19000 CAPSULE in 1 BAG
772579-900-071 BAG in 1 DRUM (72579-900-07) / 18800 CAPSULE in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC72579-900The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEDRUG FOR FURTHER PROCESSINGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMEzanubrutinibThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE10/26/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEBeOne Medicines USA, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEZANUBRUTINIBAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH80 
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 12/6/2025

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