NDC 72579-011

BRUKINSA

Zanubrutinib

BRUKINSA is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Beigene Usa, Inc.. The primary component is Zanubrutinib.

Product ID72579-011_bfa269c4-21ff-4df2-a6f0-aeaf079fd4d8
NDC72579-011
Product TypeHuman Prescription Drug
Proprietary NameBRUKINSA
Generic NameZanubrutinib
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2019-11-18
Marketing CategoryNDA / NDA
Application NumberNDA213217
Labeler NameBeigene Usa, Inc.
Substance NameZANUBRUTINIB
Active Ingredient Strength80 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72579-011-02

120 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (72579-011-02)
Marketing Start Date2019-11-18
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
ZANUBRUTINIB80 mg/1

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.