Home NDC 72579-122-01 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218785-001 BRUKINSA ZANUBRUTINIB 160MG TABLET / ORAL RLD, RS 2025-06-10
Orange Book patents# Current patent rows page 1 of 1 · 69 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218785-001 10570139 2034-04-22 U-1745 2025-06-30 N218785-001 10570139 2034-04-22 U-2145 2025-06-30 N218785-001 10570139 2034-04-22 U-2537 2025-06-30 N218785-001 10570139 2034-04-22 U-2666 2025-06-30 N218785-001 10570139 2034-04-22 U-3063 2025-06-30 N218785-001 10570139 2034-04-22 U-3486 2025-06-30 N218785-001 10570139 2034-04-22 U-3860 2025-06-30 N218785-001 11142528 2034-04-22 U-1745 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-2145 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-2537 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-2666 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-3063 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-3486 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-3860 Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2025-06-30 N218785-001 10927117 2037-08-15 Drug substance, Drug product 2025-06-30 N218785-001 11591340 2037-08-15 U-1745 2025-06-30 N218785-001 11591340 2037-08-15 U-2145 2025-06-30 N218785-001 11591340 2037-08-15 U-2537 2025-06-30 N218785-001 11591340 2037-08-15 U-2666 2025-06-30 N218785-001 11591340 2037-08-15 U-3063 2025-06-30 N218785-001 11591340 2037-08-15 U-3486 2025-06-30 N218785-001 11591340 2037-08-15 U-3727 2025-06-30 N218785-001 11591340 2037-08-15 U-3728 2025-06-30 N218785-001 11591340 2037-08-15 U-3729 2025-06-30 N218785-001 11851437 2037-08-15 Drug substance, Drug product 2025-06-30 N218785-001 11884674 2037-08-15 U-1745 2025-06-30 N218785-001 11884674 2037-08-15 U-2145 2025-06-30 N218785-001 11884674 2037-08-15 U-2537 2025-06-30 N218785-001 11884674 2037-08-15 U-2666 2025-06-30 N218785-001 11884674 2037-08-15 U-3063 2025-06-30 N218785-001 11884674 2037-08-15 U-3486 2025-06-30 N218785-001 11884674 2037-08-15 U-3860 2025-06-30 N218785-001 11970500 2037-08-15 U-1745 2025-06-30 N218785-001 11970500 2037-08-15 U-2145 2025-06-30 N218785-001 11970500 2037-08-15 U-2537 2025-06-30 N218785-001 11970500 2037-08-15 U-2666 2025-06-30 N218785-001 11970500 2037-08-15 U-3063 2025-06-30 N218785-001 11970500 2037-08-15 U-3486 2025-06-30 N218785-001 11970500 2037-08-15 U-3860 2025-06-30 N218785-001 11701357 2039-06-24 U-3860 2025-06-30 N218785-001 12233069 2040-06-10 Drug product 2025-06-30 N218785-001 11786531 2043-01-19 U-3715 2025-06-30 N218785-001 11786531 2043-01-19 U-3716 2025-06-30 N218785-001 11786531 2043-01-19 U-3717 2025-06-30 N218785-001 11786531 2043-01-19 U-3718 2025-06-30 N218785-001 11786531 2043-01-19 U-3719 2025-06-30 N218785-001 11786531 2043-01-19 U-3720 2025-06-30 N218785-001 11786531 2043-01-19 U-3875 2025-06-30 N218785-001 11896596 2043-01-19 U-3715 2025-06-30 N218785-001 11896596 2043-01-19 U-3716 2025-06-30 N218785-001 11896596 2043-01-19 U-3717 2025-06-30 N218785-001 11896596 2043-01-19 U-3718 2025-06-30 N218785-001 11896596 2043-01-19 U-3719 2025-06-30 N218785-001 11896596 2043-01-19 U-3720 2025-06-30 N218785-001 11896596 2043-01-19 U-3875 2025-06-30 N218785-001 11911386 2043-01-19 U-3715 2025-06-30 N218785-001 11911386 2043-01-19 U-3716 2025-06-30 N218785-001 11911386 2043-01-19 U-3717 2025-06-30 N218785-001 11911386 2043-01-19 U-3718 2025-06-30 N218785-001 11911386 2043-01-19 U-3719 2025-06-30 N218785-001 11911386 2043-01-19 U-3720 2025-06-30 N218785-001 11911386 2043-01-19 U-3875 2025-06-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 7 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 276 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-1745 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-3860 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-3486 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-3063 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-2666 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-2537 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10570139 2034-04-22 U-2145 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-1745 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-3860 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-3486 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-3063 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-2666 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-2537 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11142528 2034-04-22 U-2145 Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 10927117 2037-08-15 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-3728 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-3727 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-3486 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-3063 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-2666 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-2537 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-2145 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-1745 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11591340 2037-08-15 U-3729 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11851437 2037-08-15 Drug substance, Drug product 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-1745 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-3860 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-3486 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-3063 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-2666 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-2537 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11884674 2037-08-15 U-2145 2025-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218785-001 11970500 2037-08-15 U-1745 2025-06-30 011fe1cb6892…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base BRUKINSA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZANUBRUTINIB 160 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AG9MHG098Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2262440 Internal RxNorm lookup 2262446 Internal RxNorm lookup 2719220 Internal RxNorm lookup 2719223 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72579-122-01 BRUKINSA 60 in 1 BOTTLE TABLET, FILM COATED 60 22 72579-122-01 BRUKINSA 1 in 1 CARTON TABLET, FILM COATED 1 22
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72579-122-01 72579012201 1 BOTTLE in 1 CARTON (72579-122-01) / 60 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-08-18 No No Current