Alunbrig

Product NDC: 76189-113
11-digit product format: 761890113
Labeler code: 76189
Product ID: 76189-113_76928450-348f-4d49-b086-17866cfb34c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brigatinib
Dosage form: TABLET, COATED
Route: ORAL
Labeler: ARIAD Pharmaceuticals Inc.
Application: NDA208772
Marketing category: NDA
Marketing start: 2017-04-28
Marketing end: 2020-12-12
Substance: BRIGATINIB
Active strength: 30 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76189-113		D	Discontinued by firm	2026-10-02
excluded package	package	76189-113	76189-113-18	D	Discontinued by firm	2026-10-02
excluded package	package	76189-113	76189-113-21	D	Discontinued by firm	2026-10-02

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76189-113-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76189-113-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76189-113-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76189-113-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76189-113-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76189-113-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76189-113-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76189-113-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76189-113-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76189-113-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76189-113-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76189-113-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76189-113-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76189-113-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76189-113-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76189-113-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76189-113-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76189-113-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76189-113-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76189-113-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76189-113-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76189-113-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76189-113-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76189-113-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208772-001	ALUNBRIG	BRIGATINIB	30MG	TABLET / ORAL	RLD	2017-04-28
N208772-002	ALUNBRIG	BRIGATINIB	90MG	TABLET / ORAL	RLD, RS	2017-04-28
N208772-003	ALUNBRIG	BRIGATINIB	180MG	TABLET / ORAL	RLD	2017-10-02

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208772-001	9273077	2029-05-21	U-2837		2017-05-26
N208772-001	9012462	2031-04-28		Drug substance	2017-05-26
N208772-001	9611283	2034-04-10	U-2837		2017-05-26
N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10
N208772-002	9273077	2029-05-21	U-2837		2017-05-26
N208772-002	9012462	2031-04-28		Drug substance	2017-05-26
N208772-002	9611283	2034-04-10	U-2837		2017-05-26
N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10
N208772-003	9273077	2029-05-21	U-2837		2017-10-23
N208772-003	9012462	2031-04-28		Drug substance	2017-10-23
N208772-003	9611283	2034-04-10	U-2837		2017-10-23
N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208772-001	ODE-300	2027-05-22
N208772-002	ODE-300	2027-05-22
N208772-003	ODE-300	2027-05-22

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD, RS	2017-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD	2017-10-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD, RS	2017-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD	2017-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD, RS	2017-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD	2017-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 513 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 330 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N208772-001	ODE-300	2027-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-002	ODE-300	2027-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208772-003	ODE-300	2027-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208772-001	ODE-300	2027-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	ODE-300	2027-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	ODE-300	2027-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208772-001	ODE-300	2027-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	ODE-300	2027-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	ODE-300	2027-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	ODE-300	2027-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	ODE-300	2027-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	ODE-300	2027-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208772-001	ODE-300	2027-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-002	ODE-300	2027-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-003	ODE-300	2027-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-001	ODE-300	2027-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-002	ODE-300	2027-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-003	ODE-300	2027-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-001	ODE-300	2027-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-002	ODE-300	2027-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-003	ODE-300	2027-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-001	ODE-142	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-001	ODE-300	2027-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-002	ODE-142	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-002	ODE-300	2027-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-003	ODE-142	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-003	ODE-300	2027-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-001	ODE-142	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-001	ODE-300	2027-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-002	ODE-142	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-002	ODE-300	2027-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-003	ODE-142	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-003	ODE-300	2027-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-001	ODE-142	2024-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-001	ODE-300	2027-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-002	ODE-142	2024-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-002	ODE-300	2027-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-003	ODE-142	2024-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-003	ODE-300	2027-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-001	ODE-142	2024-04-28	`d8e5a09893c0…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76189-113-18	EA - Each	76189-113	135f134d-9bfd-4def-b270-45d46b1b5545	1	2017-06-15
76189-113-21	EA - Each	76189-113	1aac6a87-b6ec-4765-87e3-8a4af305ff69	1	2017-06-15

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
Alunbrig	BRIGATINIB	Takeda Pharmaceuticals America, Inc.	0fe9ff20-d402-41f3-bc1e-7002ea7007db	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208772 application number: NDA208772

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HYW8DB273J	BRIGATINIB	1197953-54-0	BRIGATINIB

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alunbrig	ARIAD Pharmaceuticals Inc. \| PENN PHARMACEUTICAL SERVICES LTD	2018-12-17	HUMAN PRESCRIPTION DRUG LABEL	2