Imbruvica

Product NDC: 57962-560
Requested package NDC: 57962-560-28
11-digit product format: 579620560
Labeler code: 57962
Product ID: 57962-560_0d02fa60-b63e-4a9d-9db2-0138cd052b33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibrutinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pharmacyclics LLC
Application: NDA210563
Marketing category: NDA
Marketing start: 2018-02-16
Marketing end: 0000-00-00
Substance: IBRUTINIB
Active strength: 560 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57962-560	57962-560-28	D	Discontinued by firm		2026-08-17

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 · 6 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210563-001	IMBRUVICA	IBRUTINIB	140MG	TABLET / ORAL	RLD	2018-02-16
N210563-002	IMBRUVICA	IBRUTINIB	280MG	TABLET / ORAL	RLD	2018-02-16
N210563-003	IMBRUVICA	IBRUTINIB	420MG	TABLET / ORAL	RLD, RS	2018-02-16
N210563-004	IMBRUVICA	IBRUTINIB	560MG	TABLET / ORAL	RLD	2018-02-16

Orange Book patents#

Current patent rows page 1 of 6 · 424 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210563-001	7514444	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	8476284	2026-12-28	U-1650		2018-03-06
N210563-001	8476284	2026-12-28	U-1946		2018-03-06
N210563-001	8476284	2026-12-28	U-2241		2018-03-06
N210563-001	8497277	2026-12-28	U-1491		2018-03-06
N210563-001	8497277	2026-12-28	U-1650		2018-03-06
N210563-001	8497277	2026-12-28	U-1946		2018-03-06
N210563-001	8497277	2026-12-28	U-2241		2018-03-06
N210563-001	8497277	2026-12-28	U-2242		2018-03-06
N210563-001	8497277	2026-12-28	U-3422		2018-03-06
N210563-001	8697711	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	8703780	2026-12-28	U-1491		2018-03-06
N210563-001	8703780	2026-12-28	U-2242		2018-03-06
N210563-001	8735403	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	8754091	2026-12-28		Drug product	2018-03-06
N210563-001	8952015	2026-12-28	U-1491		2018-03-06
N210563-001	8952015	2026-12-28	U-1650		2018-03-06
N210563-001	8952015	2026-12-28	U-1946		2018-03-06
N210563-001	8952015	2026-12-28	U-2241		2018-03-06
N210563-001	8952015	2026-12-28	U-2242		2018-03-06
N210563-001	8957079	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	9181257	2026-12-28		Drug substance	2018-03-06
N210563-001	8563563	2027-04-26	U-1491		2018-03-06
N210563-001	8563563	2027-04-26	U-1650		2018-03-06
N210563-001	8563563	2027-04-26	U-1946		2018-03-06
N210563-001	8563563	2027-04-26	U-2241		2018-03-06
N210563-001	8563563	2027-04-26	U-2242		2018-03-06
N210563-001	7514444*PED	2027-06-28		Pediatric extension
N210563-001	8476284*PED	2027-06-28		Pediatric extension
N210563-001	8497277*PED	2027-06-28		Pediatric extension
N210563-001	8697711*PED	2027-06-28		Pediatric extension
N210563-001	8703780*PED	2027-06-28		Pediatric extension
N210563-001	8735403*PED	2027-06-28		Pediatric extension
N210563-001	8754091*PED	2027-06-28		Pediatric extension
N210563-001	8952015*PED	2027-06-28		Pediatric extension
N210563-001	8957079*PED	2027-06-28		Pediatric extension
N210563-001	9181257*PED	2027-06-28		Pediatric extension
N210563-001	8563563*PED	2027-10-26		Pediatric extension
N210563-001	8008309	2027-11-13		Drug substance, Drug product	2018-03-06
N210563-001	8008309*PED	2028-05-13		Pediatric extension
N210563-001	10004746	2031-06-03	U-1684		2018-07-17
N210563-001	10004746	2031-06-03	U-1946		2018-07-17
N210563-001	10004746	2031-06-03	U-2241		2018-07-17
N210563-001	10004746	2031-06-03	U-2242		2018-07-17
N210563-001	10016435	2031-06-03	U-1650		2018-08-02
N210563-001	10478439	2031-06-03	U-1650		2019-12-10
N210563-001	10478439	2031-06-03	U-1684		2019-12-10
N210563-001	10478439	2031-06-03	U-1946		2019-12-10
N210563-001	10478439	2031-06-03	U-2241		2019-12-10
N210563-001	10478439	2031-06-03	U-2242		2019-12-10
N210563-001	10478439	2031-06-03	U-2665		2019-12-10
N210563-001	10478439	2031-06-03	U-3422		2019-12-10
N210563-001	10751342	2031-06-03	U-1491		2020-09-10
N210563-001	10751342	2031-06-03	U-1946		2020-09-10
N210563-001	10751342	2031-06-03	U-2943		2020-09-10
N210563-001	10751342	2031-06-03	U-2944		2020-09-10
N210563-001	11672803	2031-06-03	U-1684		2023-07-14
N210563-001	11672803	2031-06-03	U-1946		2023-07-14
N210563-001	11672803	2031-06-03	U-2241		2023-07-14
N210563-001	11672803	2031-06-03	U-2242		2023-07-14
N210563-001	8999999	2031-06-03	U-1491		2018-03-06
N210563-001	8999999	2031-06-03	U-1946		2018-03-06
N210563-001	8999999	2031-06-03	U-2241		2018-03-06
N210563-001	8999999	2031-06-03	U-2242		2018-03-06
N210563-001	9125889	2031-06-03	U-1650		2018-03-06
N210563-001	9801881	2031-06-03	U-1491		2018-03-06
N210563-001	9801881	2031-06-03	U-2242		2018-03-06
N210563-001	9801883	2031-06-03	U-2159		2018-03-06
N210563-001	9801883	2031-06-03	U-2243		2018-03-06
N210563-001	10004746*PED	2031-12-03		Pediatric extension
N210563-001	10016435*PED	2031-12-03		Pediatric extension
N210563-001	10478439*PED	2031-12-03		Pediatric extension
N210563-001	10751342*PED	2031-12-03		Pediatric extension
N210563-001	8999999*PED	2031-12-03		Pediatric extension
N210563-001	9125889*PED	2031-12-03		Pediatric extension
N210563-001	9801881*PED	2031-12-03		Pediatric extension
N210563-001	9801883*PED	2031-12-03		Pediatric extension
N210563-001	10106548	2033-06-03		Drug substance, Drug product	2018-10-26
N210563-001	10125140	2033-06-03		Drug substance, Drug product	2018-11-16
N210563-001	10752634	2033-06-03		Drug product	2020-09-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 16 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210563-001	NPP	2025-08-24
N210563-001	PED	2026-02-24
N210563-001	ODE-405	2029-08-24
N210563-001	PED	2030-02-24
N210563-002	NPP	2025-08-24
N210563-002	PED	2026-02-24
N210563-002	ODE-405	2029-08-24
N210563-002	PED	2030-02-24
N210563-003	NPP	2025-08-24
N210563-003	PED	2026-02-24
N210563-003	ODE-405	2029-08-24
N210563-003	PED	2030-02-24
N210563-004	NPP	2025-08-24
N210563-004	PED	2026-02-24
N210563-004	ODE-405	2029-08-24
N210563-004	PED	2030-02-24

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 5 · 168 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	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 403 · 16,117 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	N210563-001	7514444	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284	2026-12-28	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284	2026-12-28	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284	2026-12-28	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-3422		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8697711	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8703780	2026-12-28	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8703780	2026-12-28	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8735403	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8754091	2026-12-28		Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8957079	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	9181257	2026-12-28		Drug substance	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	7514444*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8697711*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8703780*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8735403*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8754091*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8957079*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	9181257*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563*PED	2027-10-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8008309	2027-11-13		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8008309*PED	2028-05-13		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 668 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	N210563-001	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	PED	2030-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210563-001	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-001	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-001	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-001	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	PED	2030-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	M-14	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	NPP	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	PED	2026-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	ODE-405	2029-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	PED	2030-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	M-14	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	NPP	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	PED	2026-02-24	`31067a03dcf5…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57962-560-28	EA - Each	57962-560	56d0193b-907e-4d3a-8e0f-fb58bb4e86d3	1	2018-03-08

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
Imbruvica	IBRUTINIB	Pharmacyclics LLC	0dfd0279-ff17-4ea9-89be-9803c71bab44	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210563 application number: NDA210563

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1X70OSD4VX	IBRUTINIB	936563-96-1	IBRUTINIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57962-560-28	57962056028	1 BLISTER PACK in 1 CARTON (57962-560-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2018-02-16	0000-00-00	No	No	Current