Imbruvica
- Product NDC
- 57962-560
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 57962-560 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 57962-560 | 57962-560-28 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 57962-560 | 57962-560-71 | 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.
| 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 | 57962-560-71 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 57962-560-28 | 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 | 57962-560-71 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 57962-560-28 | 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 | 57962-560-71 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 57962-560-28 | 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 | 57962-560-71 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 57962-560-28 | 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 | 57962-560-71 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 57962-560-28 | 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 | 57962-560-71 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 57962-560-28 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 57962-560-71 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 57962-560-71 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 57962-560-71 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 57962-560-71 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 57962-560-71 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 57962-560-71 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | 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#
| 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#
| 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 | 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.
| 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 | 210563 NDA210563 |
Packages#
| 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 |