FDA.reportPublic FDA data

BRUKINSA

Product NDC
72579-011
11-digit product format
725790011
Labeler code
72579
Product ID
72579-011_cb0c9753-cca4-421e-9512-1b710a56b342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zanubrutinib
Dosage form
CAPSULE
Route
ORAL
Labeler
BeOne Medicines USA, Inc.
Application
NDA213217
Marketing category
NDA
Marketing start
2019-11-14
Substance
ZANUBRUTINIB
Active strength
80 mg/1
Pharmacologic classes
Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRUKINSA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZANUBRUTINIB80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAG9MHG098Z
Rxcui2262440, 2262446, 2719220, 2719223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6511ac-9936-4e22-a18a-3d3144ad16b3Product name120200428

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72579-011-01BRUKINSA60 in 1 BOTTLE, PLASTICCAPSULE6022
72579-011-01BRUKINSA1 in 1 CARTONCAPSULE122
72579-011-02BRUKINSA1 in 1 CARTONCAPSULE122
72579-011-02BRUKINSA120 in 1 BOTTLE, PLASTICCAPSULE12022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72579-011-02EA - Each72579-0114de8a513-e359-477e-a5b7-b1e34287082412019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72579-011BRUKINSA (ZANUBRUTINIB) CAPSULE [BEONE MEDICINES USA, INC.]17Current NDC, Legacy NDC, 4 package rows20250411_3e08fe23-d70e-424c-bc51-1222e320f902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719223Brukinsa 160 MG Oral TabletPSN3e08fe23-d70e-424c-bc51-1222e320f90222
2262446Brukinsa 80 MG Oral CapsulePSN3e08fe23-d70e-424c-bc51-1222e320f90222
2719220zanubrutinib 160 MG Oral TabletPSN3e08fe23-d70e-424c-bc51-1222e320f90222
2262440zanubrutinib 80 MG Oral CapsulePSN3e08fe23-d70e-424c-bc51-1222e320f90222
2719223zanubrutinib 160 MG Oral Tablet [Brukinsa]SBD3e08fe23-d70e-424c-bc51-1222e320f90222
2262446zanubrutinib 80 MG Oral Capsule [Brukinsa]SBD3e08fe23-d70e-424c-bc51-1222e320f90222
2719220zanubrutinib 160 MG Oral TabletSCD3e08fe23-d70e-424c-bc51-1222e320f90222
2262440zanubrutinib 80 MG Oral CapsuleSCD3e08fe23-d70e-424c-bc51-1222e320f90222
2719223Brukinsa 160 MG Oral TabletSY3e08fe23-d70e-424c-bc51-1222e320f90222
2262446Brukinsa 80 MG Oral CapsuleSY3e08fe23-d70e-424c-bc51-1222e320f90222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72579-011-017257900110160 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (72579-011-01) 2019-11-180000-00-00NoNoCurrent
72579-011-02725790011021 BOTTLE, PLASTIC in 1 CARTON (72579-011-02) / 120 CAPSULE in 1 BOTTLE, PLASTIC2019-11-140000-00-00NoNoCurrent