BRUKINSA

Product NDC
72579-122
Requested package NDC
72579-122-01
11-digit product format
725790122
Labeler code
72579
Product ID
72579-122_cb0c9753-cca4-421e-9512-1b710a56b342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zanubrutinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BeOne Medicines USA, Inc.
Application
NDA218785
Marketing category
NDA
Marketing start
2025-08-18
Substance
ZANUBRUTINIB
Active strength
160 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218785-001BRUKINSAZANUBRUTINIB160MGTABLET / ORALRLD, RS2025-06-10

Orange Book patents#

Current patent rows page 1 of 1 · 69 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218785-001105701392034-04-22U-17452025-06-30
N218785-001105701392034-04-22U-21452025-06-30
N218785-001105701392034-04-22U-25372025-06-30
N218785-001105701392034-04-22U-26662025-06-30
N218785-001105701392034-04-22U-30632025-06-30
N218785-001105701392034-04-22U-34862025-06-30
N218785-001105701392034-04-22U-38602025-06-30
N218785-001111425282034-04-22U-1745Drug product2025-06-30
N218785-001111425282034-04-22U-2145Drug product2025-06-30
N218785-001111425282034-04-22U-2537Drug product2025-06-30
N218785-001111425282034-04-22U-2666Drug product2025-06-30
N218785-001111425282034-04-22U-3063Drug product2025-06-30
N218785-001111425282034-04-22U-3486Drug product2025-06-30
N218785-001111425282034-04-22U-3860Drug product2025-06-30
N218785-00194471062034-04-22U-1745Drug substance, Drug product2025-06-30
N218785-00194471062034-04-22U-2145Drug substance, Drug product2025-06-30
N218785-00194471062034-04-22U-2537Drug substance, Drug product2025-06-30
N218785-00194471062034-04-22U-2666Drug substance, Drug product2025-06-30
N218785-00194471062034-04-22U-3063Drug substance, Drug product2025-06-30
N218785-00194471062034-04-22U-3486Drug substance, Drug product2025-06-30
N218785-00194471062034-04-22U-3860Drug substance, Drug product2025-06-30
N218785-001109271172037-08-15Drug substance, Drug product2025-06-30
N218785-001115913402037-08-15U-17452025-06-30
N218785-001115913402037-08-15U-21452025-06-30
N218785-001115913402037-08-15U-25372025-06-30
N218785-001115913402037-08-15U-26662025-06-30
N218785-001115913402037-08-15U-30632025-06-30
N218785-001115913402037-08-15U-34862025-06-30
N218785-001115913402037-08-15U-37272025-06-30
N218785-001115913402037-08-15U-37282025-06-30
N218785-001115913402037-08-15U-37292025-06-30
N218785-001118514372037-08-15Drug substance, Drug product2025-06-30
N218785-001118846742037-08-15U-17452025-06-30
N218785-001118846742037-08-15U-21452025-06-30
N218785-001118846742037-08-15U-25372025-06-30
N218785-001118846742037-08-15U-26662025-06-30
N218785-001118846742037-08-15U-30632025-06-30
N218785-001118846742037-08-15U-34862025-06-30
N218785-001118846742037-08-15U-38602025-06-30
N218785-001119705002037-08-15U-17452025-06-30
N218785-001119705002037-08-15U-21452025-06-30
N218785-001119705002037-08-15U-25372025-06-30
N218785-001119705002037-08-15U-26662025-06-30
N218785-001119705002037-08-15U-30632025-06-30
N218785-001119705002037-08-15U-34862025-06-30
N218785-001119705002037-08-15U-38602025-06-30
N218785-001117013572039-06-24U-38602025-06-30
N218785-001122330692040-06-10Drug product2025-06-30
N218785-001117865312043-01-19U-37152025-06-30
N218785-001117865312043-01-19U-37162025-06-30
N218785-001117865312043-01-19U-37172025-06-30
N218785-001117865312043-01-19U-37182025-06-30
N218785-001117865312043-01-19U-37192025-06-30
N218785-001117865312043-01-19U-37202025-06-30
N218785-001117865312043-01-19U-38752025-06-30
N218785-001118965962043-01-19U-37152025-06-30
N218785-001118965962043-01-19U-37162025-06-30
N218785-001118965962043-01-19U-37172025-06-30
N218785-001118965962043-01-19U-37182025-06-30
N218785-001118965962043-01-19U-37192025-06-30
N218785-001118965962043-01-19U-37202025-06-30
N218785-001118965962043-01-19U-38752025-06-30
N218785-001119113862043-01-19U-37152025-06-30
N218785-001119113862043-01-19U-37162025-06-30
N218785-001119113862043-01-19U-37172025-06-30
N218785-001119113862043-01-19U-37182025-06-30
N218785-001119113862043-01-19U-37192025-06-30
N218785-001119113862043-01-19U-37202025-06-30
N218785-001119113862043-01-19U-38752025-06-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218785-001I-8172026-01-19
N218785-001ODE*2026-11-14
N218785-001I-9362027-03-07
N218785-001ODE*2028-08-31
N218785-001ODE*2028-09-14
N218785-001ODE*2030-01-19
N218785-001ODE*2031-03-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218785-001BRUKINSA160MGTABLET / ORALRLD, RS2025-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001BRUKINSA160MGTABLET / ORALRLD, RS2025-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N218785-001BRUKINSA160MGTABLET / ORALRLD, RS2025-06-106a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001BRUKINSA160MGTABLET / ORALRLD, RS2025-06-10a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 7 · 276 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-17452025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-38602025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-34862025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-30632025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-26662025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-25372025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001105701392034-04-22U-21452025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-1745Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-3860Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-3486Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-3063Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-2666Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-2537Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001111425282034-04-22U-2145Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-1745Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-2145Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-2537Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-2666Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-3063Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-3486Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-00194471062034-04-22U-3860Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001109271172037-08-15Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-37282025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-37272025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-34862025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-30632025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-26662025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-25372025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-21452025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-17452025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001115913402037-08-15U-37292025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118514372037-08-15Drug substance, Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-17452025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-38602025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-34862025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-30632025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-26662025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-25372025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001118846742037-08-15U-21452025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001119705002037-08-15U-17452025-06-30011fe1cb6892…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N218785-001I-8172026-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001ODE*2026-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001I-9362027-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001ODE*2028-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001ODE*2028-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001ODE*2030-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218785-001ODE*2031-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001I-8172026-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001ODE*2026-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001I-9362027-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001ODE*2028-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001ODE*2028-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001ODE*2030-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218785-001ODE*2031-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N218785-001I-8172026-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218785-001ODE*2026-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218785-001I-9362027-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218785-001ODE*2028-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218785-001ODE*2028-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218785-001ODE*2030-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218785-001ODE*2031-03-076a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001I-8172026-01-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001ODE*2026-11-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001I-9362027-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001ODE*2028-08-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001ODE*2028-09-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001ODE*2030-01-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218785-001ODE*2031-03-07a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZANUBRUTINIB160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AG9MHG098ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2262440Internal RxNorm lookup
2262446Internal RxNorm lookup
2719220Internal RxNorm lookup
2719223Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e08fe23-d70e-424c-bc51-1222e320f902Available on FDA.report

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
72579-122-01BRUKINSA60 in 1 BOTTLETABLET, FILM COATED6022
72579-122-01BRUKINSA1 in 1 CARTONTABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72579-122-01EA - Each72579-12204c05ca9-d61f-41f3-838e-79f5afa8d68512025-09-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRUKINSAZANUBRUTINIBBeOne Medicines USA, Inc.3e08fe23-d70e-424c-bc51-1222e320f9022026-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 218785
application number: NDA218785
ndc (package): 72579-122-01
ndc (product): 72579-122
ndc11 (package): 72579012201

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
72579-122-01725790122011 BOTTLE in 1 CARTON (72579-122-01) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-08-18NoNoCurrent