Alunbrig

Product NDC: 63020-180
11-digit product format: 630200180
Labeler code: 63020
Product ID: 63020-180_176eb255-05c0-4cfc-874f-1fb57136d34d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brigatinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA208772
Marketing category: NDA
Marketing start: 2017-04-28
Substance: BRIGATINIB
Active strength: 180 mg/1
Pharmacologic classes: Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
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 42.

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 501 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 327 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-001	ODE-300	2027-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-002	ODE-142	2024-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-002	ODE-300	2027-05-22	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRIGATINIB	180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HYW8DB273J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1921222	Internal RxNorm lookup
1921228	Internal RxNorm lookup
1925494	Internal RxNorm lookup
1988768	Internal RxNorm lookup
1988770	Internal RxNorm lookup
1988772	Internal RxNorm lookup
1988785	Internal RxNorm lookup
1988786	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
0fe9ff20-d402-41f3-bc1e-7002ea7007db	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7e54a2c5-e3f2-4273-8a10-321aacfdbb07	Product name	2	20201030

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63020-180-30	2025-08-18	C162847	48780-1	3b156c62-273c-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017
63020-180-30	2025-07-29	C162847	48780-1	3b156c62-273c-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63020-180-23	Alunbrig	23 in 1 BOTTLE	TABLET, FILM COATED	23	180 mg	17
63020-180-30	Alunbrig	30 in 1 BOTTLE	TABLET, FILM COATED	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63020-180-30	EA - Each	63020-180	c03a66ac-ea02-4c90-b24c-0863cb10fa3e	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63020-180	ALUNBRIG (BRIGATINIB) TABLET, FILM COATED ALUNBRIG (BRIGATINIB) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20241030_0fe9ff20-d402-41f3-bc1e-7002ea7007db.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
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 ndc (product): 63020-180

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1988786	{23 (brigatinib 180 MG Oral Tablet [Alunbrig]) / 7 (brigatinib 90 MG Oral Tablet [Alunbrig]) } Pack [Alunbrig Initiation Pack]	BPCK	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988785	{23 (brigatinib 180 MG Oral Tablet) / 7 (brigatinib 90 MG Oral Tablet) } Pack	GPCK	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988772	ALUNBRIG 180 MG Oral Tablet	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1921228	ALUNBRIG 30 MG Oral Tablet	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988768	ALUNBRIG 90 MG Oral Tablet	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988786	ALUNBRIG Initiation Pack	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988770	brigatinib 180 MG Oral Tablet	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988785	brigatinib 180 MG Oral Tablet (23) / brigatinib 90 MG Oral Tablet (7) Pack	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1921222	brigatinib 30 MG Oral Tablet	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1925494	brigatinib 90 MG Oral Tablet	PSN	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988772	brigatinib 180 MG Oral Tablet [Alunbrig]	SBD	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1921228	brigatinib 30 MG Oral Tablet [Alunbrig]	SBD	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988768	brigatinib 90 MG Oral Tablet [Alunbrig]	SBD	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988770	brigatinib 180 MG Oral Tablet	SCD	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1921222	brigatinib 30 MG Oral Tablet	SCD	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1925494	brigatinib 90 MG Oral Tablet	SCD	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988772	Alunbrig 180 MG Oral Tablet	SY	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1921228	Alunbrig 30 MG Oral Tablet	SY	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988768	Alunbrig 90 MG Oral Tablet	SY	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17
1988786	Alunbrig Initiation Pack	SY	0fe9ff20-d402-41f3-bc1e-7002ea7007db	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63020-180-23	63020018023	23 in 1 BOTTLE					Historical
63020-180-30	63020018030	30 TABLET, FILM COATED in 1 BOTTLE (63020-180-30)	2017-10-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alunbrig	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL	17