BRUKINSA

Product NDC: 72579-011
Requested package NDC: 72579-011-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72579-011	72579-011-01	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N213217-001	BRUKINSA	ZANUBRUTINIB	80MG	CAPSULE / ORAL		RLD	2019-11-14

Orange Book patents#

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213217-001	10570139	2034-04-22	U-1745		2021-06-04
N213217-001	10570139	2034-04-22	U-2145		2021-06-04
N213217-001	10570139	2034-04-22	U-2537		2021-06-04
N213217-001	10570139	2034-04-22	U-2666		2021-06-04
N213217-001	10570139	2034-04-22	U-3063		2021-06-04
N213217-001	10570139	2034-04-22	U-3486		2021-06-04
N213217-001	10570139	2034-04-22	U-3860		2021-06-04
N213217-001	11142528	2034-04-22	U-1745	Drug product	2021-11-12
N213217-001	11142528	2034-04-22	U-2145	Drug product	2021-11-12
N213217-001	11142528	2034-04-22	U-2537	Drug product	2021-11-12
N213217-001	11142528	2034-04-22	U-2666	Drug product	2021-11-12
N213217-001	11142528	2034-04-22	U-3063	Drug product	2021-11-12
N213217-001	11142528	2034-04-22	U-3486	Drug product	2021-11-12
N213217-001	11142528	2034-04-22	U-3860	Drug product	2021-11-12
N213217-001	9447106	2034-04-22	U-1745	Drug substance, Drug product	2019-11-20
N213217-001	9447106	2034-04-22	U-2145	Drug substance, Drug product	2019-11-20
N213217-001	9447106	2034-04-22	U-2537	Drug substance, Drug product	2019-11-20
N213217-001	9447106	2034-04-22	U-2666	Drug substance, Drug product	2019-11-20
N213217-001	9447106	2034-04-22	U-3063	Drug substance, Drug product	2019-11-20
N213217-001	9447106	2034-04-22	U-3486	Drug substance, Drug product	2019-11-20
N213217-001	9447106	2034-04-22	U-3860	Drug substance, Drug product	2019-11-20
N213217-001	10927117	2037-08-15		Drug substance, Drug product	2021-04-20
N213217-001	11591340	2037-08-15	U-1745		2023-03-08
N213217-001	11591340	2037-08-15	U-2145		2023-03-08
N213217-001	11591340	2037-08-15	U-2537		2023-03-08
N213217-001	11591340	2037-08-15	U-2666		2023-03-08
N213217-001	11591340	2037-08-15	U-3063		2023-03-08
N213217-001	11591340	2037-08-15	U-3486		2023-03-08
N213217-001	11591340	2037-08-15	U-3727		2023-03-08
N213217-001	11591340	2037-08-15	U-3728		2023-03-08
N213217-001	11591340	2037-08-15	U-3729		2023-03-08
N213217-001	11851437	2037-08-15		Drug substance, Drug product	2024-01-23
N213217-001	11884674	2037-08-15	U-1745		2024-02-28
N213217-001	11884674	2037-08-15	U-2145		2024-02-28
N213217-001	11884674	2037-08-15	U-2537		2024-02-28
N213217-001	11884674	2037-08-15	U-2666		2024-02-28
N213217-001	11884674	2037-08-15	U-3063		2024-02-28
N213217-001	11884674	2037-08-15	U-3486		2024-02-28
N213217-001	11884674	2037-08-15	U-3860		2024-02-28
N213217-001	11970500	2037-08-15	U-1745		2024-05-09
N213217-001	11970500	2037-08-15	U-2145		2024-05-09
N213217-001	11970500	2037-08-15	U-2537		2024-05-09
N213217-001	11970500	2037-08-15	U-2666		2024-05-09
N213217-001	11970500	2037-08-15	U-3063		2024-05-09
N213217-001	11970500	2037-08-15	U-3486		2024-05-09
N213217-001	11970500	2037-08-15	U-3860		2024-05-09
N213217-001	11701357	2039-06-24	U-3860		2024-04-02
N213217-001	11786531	2043-01-19	U-3715		2023-11-02
N213217-001	11786531	2043-01-19	U-3716		2023-11-02
N213217-001	11786531	2043-01-19	U-3717		2023-11-02
N213217-001	11786531	2043-01-19	U-3718		2023-11-02
N213217-001	11786531	2043-01-19	U-3719		2023-11-02
N213217-001	11786531	2043-01-19	U-3720		2023-11-02
N213217-001	11786531	2043-01-19	U-3875		2023-11-02
N213217-001	11896596	2043-01-19	U-3715		2024-03-12
N213217-001	11896596	2043-01-19	U-3716		2024-03-12
N213217-001	11896596	2043-01-19	U-3717		2024-03-12
N213217-001	11896596	2043-01-19	U-3718		2024-03-12
N213217-001	11896596	2043-01-19	U-3719		2024-03-12
N213217-001	11896596	2043-01-19	U-3720		2024-03-12
N213217-001	11896596	2043-01-19	U-3875		2024-03-12
N213217-001	11911386	2043-01-19	U-3715		2024-02-28
N213217-001	11911386	2043-01-19	U-3716		2024-02-28
N213217-001	11911386	2043-01-19	U-3717		2024-02-28
N213217-001	11911386	2043-01-19	U-3718		2024-02-28
N213217-001	11911386	2043-01-19	U-3719		2024-02-28
N213217-001	11911386	2043-01-19	U-3720		2024-02-28
N213217-001	11911386	2043-01-19	U-3875		2024-02-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213217-001	I-817	2026-01-19
N213217-001	ODE-276	2026-11-14
N213217-001	I-936	2027-03-07
N213217-001	ODE-371	2028-08-31
N213217-001	ODE-370	2028-09-14
N213217-001	ODE-274	2030-01-19
N213217-001	ODE-467	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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD	2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD	2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD, RS	2019-11-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213217-001	BRUKINSA	80MG	CAPSULE / ORAL	RLD	2019-11-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,356 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	N213217-001	10570139	2034-04-22	U-1745		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10570139	2034-04-22	U-2666		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10570139	2034-04-22	U-2537		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10570139	2034-04-22	U-3860		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10570139	2034-04-22	U-3063		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10570139	2034-04-22	U-3486		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10570139	2034-04-22	U-2145		2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-2666	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-2537	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-1745	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-2145	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-3063	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-3860	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11142528	2034-04-22	U-3486	Drug product	2021-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-2145	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-1745	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-3063	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-2537	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-2666	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-3860	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	9447106	2034-04-22	U-3486	Drug substance, Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	10927117	2037-08-15		Drug substance, Drug product	2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-1745		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-2145		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-2537		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-2666		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-3063		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-3486		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-3727		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-3729		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11591340	2037-08-15	U-3728		2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11851437	2037-08-15		Drug substance, Drug product	2024-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-1745		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-2145		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-2537		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-2666		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-3063		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-3486		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11884674	2037-08-15	U-3860		2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	11970500	2037-08-15	U-1745		2024-05-09	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 263 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213217-001	I-817	2026-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	ODE-276	2026-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	I-936	2027-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	ODE-371	2028-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	ODE-370	2028-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	ODE-274	2030-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213217-001	ODE-467	2031-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	I-817	2026-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	ODE-276	2026-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	I-936	2027-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	ODE-371	2028-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	ODE-370	2028-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	ODE-274	2030-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213217-001	ODE-467	2031-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213217-001	I-817	2026-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213217-001	ODE-276	2026-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213217-001	I-936	2027-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213217-001	ODE-371	2028-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213217-001	ODE-370	2028-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213217-001	ODE-274	2030-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213217-001	ODE-467	2031-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	I-817	2026-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	ODE-276	2026-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	I-936	2027-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	ODE-371	2028-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	ODE-370	2028-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	ODE-274	2030-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213217-001	ODE-467	2031-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	I-817	2026-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	ODE-276	2026-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	I-936	2027-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	ODE-371	2028-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	ODE-370	2028-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	ODE-274	2030-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213217-001	ODE-467	2031-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213217-001	I-871	2024-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213217-001	I-874	2024-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213217-001	NCE	2024-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213217-001	I-817	2026-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213217-001	ODE-276	2026-11-14	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZANUBRUTINIB	80 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3e08fe23-d70e-424c-bc51-1222e320f902	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6511ac-9936-4e22-a18a-3d3144ad16b3	Product name	1	20200428

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72579-011-01	BRUKINSA	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	22
72579-011-01	BRUKINSA	1 in 1 CARTON	CAPSULE	1	22
72579-011-02	BRUKINSA	1 in 1 CARTON	CAPSULE	1	22
72579-011-02	BRUKINSA	120 in 1 BOTTLE, PLASTIC	CAPSULE	120	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72579-011-02	EA - Each	72579-011	4de8a513-e359-477e-a5b7-b1e342870824	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72579-011	BRUKINSA (ZANUBRUTINIB) CAPSULE [BEONE MEDICINES USA, INC.]	17	Current NDC, Legacy NDC, 4 package rows	20250411_3e08fe23-d70e-424c-bc51-1222e320f902.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRUKINSA	ZANUBRUTINIB	BeOne Medicines USA, Inc.	3e08fe23-d70e-424c-bc51-1222e320f902	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213217 application number: NDA213217 ndc (package): 72579-011-01 ndc (product): 72579-011 ndc11 (package): 72579001101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AG9MHG098Z	ZANUBRUTINIB	1691249-45-2	ZANUBRUTINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2719223	Brukinsa 160 MG Oral Tablet	PSN	3e08fe23-d70e-424c-bc51-1222e320f902	22
2262446	Brukinsa 80 MG Oral Capsule	PSN	3e08fe23-d70e-424c-bc51-1222e320f902	22
2719220	zanubrutinib 160 MG Oral Tablet	PSN	3e08fe23-d70e-424c-bc51-1222e320f902	22
2262440	zanubrutinib 80 MG Oral Capsule	PSN	3e08fe23-d70e-424c-bc51-1222e320f902	22
2719223	zanubrutinib 160 MG Oral Tablet [Brukinsa]	SBD	3e08fe23-d70e-424c-bc51-1222e320f902	22
2262446	zanubrutinib 80 MG Oral Capsule [Brukinsa]	SBD	3e08fe23-d70e-424c-bc51-1222e320f902	22
2719220	zanubrutinib 160 MG Oral Tablet	SCD	3e08fe23-d70e-424c-bc51-1222e320f902	22
2262440	zanubrutinib 80 MG Oral Capsule	SCD	3e08fe23-d70e-424c-bc51-1222e320f902	22
2719223	Brukinsa 160 MG Oral Tablet	SY	3e08fe23-d70e-424c-bc51-1222e320f902	22
2262446	Brukinsa 80 MG Oral Capsule	SY	3e08fe23-d70e-424c-bc51-1222e320f902	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72579-011-01	72579001101	1 BOTTLE, PLASTIC in 1 CARTON (72579-011-01) > 60 CAPSULE in 1 BOTTLE, PLASTIC	2019-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BRUKINSA	BeOne Medicines USA, Inc. \| AndersonBrecon Inc. \| Changzhou SynTheAll Pharmaceutical Co., Ltd \| Catalent CTS, LLC \| BeOne Pharmaceutical (Suzhou) Co.,Ltd \| Catalent Pharma Solutions, LLC \| Allpack Group AG \| Siegfried Evionnaz SA \| Sharp Packaging Services, LLC	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	24