FDA.reportPublic FDA data

BRUKINSA

Product NDC
72579-122
11-digit product format
725790122
Labeler code
72579
Product ID
72579-122_23c53429-0c0d-4acc-bdee-3ed47625db4a
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 43.

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
2026-09-14 22:38:342026-08N218785-001BRUKINSA160MGTABLET / ORALRLD, RS2025-06-1084e616aacf4f…
2026-08-18 06:07:402026-07N218785-001BRUKINSA160MGTABLET / ORALRLD, RS2025-06-10caaa826d4ba7…
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 11 · 414 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-17452025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-38602025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-34862025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-30632025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-26662025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-25372025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001105701392034-04-22U-21452025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-1745Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-3860Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-3486Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-3063Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-2666Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-2537Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001111425282034-04-22U-2145Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-1745Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-2145Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-2537Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-2666Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-3063Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-3486Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-00194471062034-04-22U-3860Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001109271172037-08-15Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-37282025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-37272025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-34862025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-30632025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-26662025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-25372025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-21452025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-17452025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001115913402037-08-15U-37292025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118514372037-08-15Drug substance, Drug product2025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-17452025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-38602025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-34862025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-30632025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-26662025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-25372025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001118846742037-08-15U-21452025-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N218785-001119705002037-08-15U-17452025-06-3084e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218785-001I-8172026-01-1984e616aacf4f…
2026-09-14 22:38:342026-08N218785-001ODE*2026-11-1484e616aacf4f…
2026-09-14 22:38:342026-08N218785-001I-9362027-03-0784e616aacf4f…
2026-09-14 22:38:342026-08N218785-001ODE*2028-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N218785-001ODE*2028-09-1484e616aacf4f…
2026-09-14 22:38:342026-08N218785-001ODE*2030-01-1984e616aacf4f…
2026-09-14 22:38:342026-08N218785-001ODE*2031-03-0784e616aacf4f…
2026-08-18 06:07:402026-07N218785-001I-8172026-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218785-001ODE*2026-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07N218785-001I-9362027-03-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218785-001ODE*2028-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N218785-001ODE*2028-09-14caaa826d4ba7…
2026-08-18 06:07:402026-07N218785-001ODE*2030-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218785-001ODE*2031-03-07caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZANUBRUTINIB160 mg/1

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

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