Home NDC 57962-007 Imbruvica
Product NDC 57962-007
11-digit product format 579620007
Labeler code 57962
Product ID 57962-007_43280dcb-52ae-40e4-bd52-723f71f74ab7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibrutinib
Dosage form SUSPENSION
Route ORAL
Labeler Pharmacyclics LLC
Application NDA217003
Marketing category NDA
Marketing start 2022-08-24
Substance IBRUTINIB
Active strength 70 mg/mL
Pharmacologic classes Kinase Inhibitor [EPC], Protein 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217003-001 IMBRUVICA IBRUTINIB 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24
Orange Book patents# Current patent rows page 1 of 2 · 86 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217003-001 IMBRUVICA 70MG/ML SUSPENSION / ORAL RLD, RS 2022-08-24 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 41 · 1,639 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 N217003-001 7514444 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8476284 2026-12-28 U-3843 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8476284 2026-12-28 U-3844 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8476284 2026-12-28 U-3845 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3422 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3842 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3843 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3845 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-3844 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-2666 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277 2026-12-28 U-2970 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8697711 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8703780 2026-12-28 U-2666 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8703780 2026-12-28 U-3842 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8735403 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8754091 2026-12-28 Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-2666 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3842 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3843 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3844 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8952015 2026-12-28 U-3845 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8957079 2026-12-28 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 9181257 2026-12-28 Drug substance 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3844 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3843 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3842 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-2666 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8563563 2027-04-26 U-3845 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 7514444*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8497277*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8697711*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8735403*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8754091*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8957079*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 9181257*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8008309 2027-11-13 Drug substance, Drug product 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 8008309*PED 2028-05-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 10004746 2031-06-03 U-3846 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 10004746 2031-06-03 U-3848 2024-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217003-001 10004746 2031-06-03 U-3849 2024-03-19 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 102 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imbruvica
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBRUTINIB 70 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1X70OSD4VX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1442986 Internal RxNorm lookup 1442992 Internal RxNorm lookup 1994360 Internal RxNorm lookup 1994362 Internal RxNorm lookup 2000017 Internal RxNorm lookup 2000019 Internal RxNorm lookup 2000021 Internal RxNorm lookup 2000023 Internal RxNorm lookup 2000025 Internal RxNorm lookup 2000027 Internal RxNorm lookup 2611536 Internal RxNorm lookup 2611540 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-08-04 These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA ® (ibrutinib) capsules, for oral use IMBRUVICA ® (ibrutinib) tablets, for oral use IMBRUVICA ® (ibrutinib) oral suspension Initial U.S. Approval: 2013 2025-08-04 These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA ® (ibrutinib) capsules, for oral use IMBRUVICA ® (ibrutinib) tablets, for oral use IMBRUVICA ® (ibrutinib) oral suspension Initial U.S. Approval: 2013 2025-08-04 These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA ® (ibrutinib) capsules, for oral use IMBRUVICA ® (ibrutinib) tablets, for oral use IMBRUVICA ® (ibrutinib) oral suspension Initial U.S. Approval: 2013 2025-07-29 These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA ® (ibrutinib) capsules, for oral use IMBRUVICA ® (ibrutinib) tablets, for oral use IMBRUVICA ® (ibrutinib) oral suspension Initial U.S. Approval: 2013 2025-07-29 These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA ® (ibrutinib) capsules, for oral use IMBRUVICA ® (ibrutinib) tablets, for oral use IMBRUVICA ® (ibrutinib) oral suspension Initial U.S. Approval: 2013 2025-07-29 These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA ® (ibrutinib) capsules, for oral use IMBRUVICA ® (ibrutinib) tablets, for oral use IMBRUVICA ® (ibrutinib) oral suspension Initial U.S. Approval: 2013
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57962-007-12 Imbruvica 1 in 1 CARTON SUSPENSION 1 65 57962-007-12 Imbruvica 108 mL in 1 BOTTLE, GLASS SUSPENSION 108 65
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57962-007 IMBRUVICA (IBRUTINIB) CAPSULE IMBRUVICA (IBRUTINIB) TABLET, FILM COATED IMBRUVICA (IBRUTINIB) SUSPENSION [PHARMACYCLICS LLC] 60 Current NDC, Legacy NDC, 2 package rows 20250309_0dfd0279-ff17-4ea9-89be-9803c71bab44.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57962-007-12 57962000712 1 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS 2022-08-24 0000-00-00 No No Current