Home NDC 57962-070 Imbruvica
Product NDC 57962-070
11-digit product format 579620070
Labeler code 57962
Product ID 57962-070_43280dcb-52ae-40e4-bd52-723f71f74ab7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibrutinib
Dosage form CAPSULE
Route ORAL
Labeler Pharmacyclics LLC
Application NDA205552
Marketing category NDA
Marketing start 2017-12-20
Substance IBRUTINIB
Active strength 70 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205552-001 IMBRUVICA IBRUTINIB 140MG CAPSULE / ORAL RLD, RS 2013-11-13 N205552-002 IMBRUVICA IBRUTINIB 70MG CAPSULE / ORAL RLD 2017-12-20
Orange Book patents# Current patent rows page 1 of 3 · 196 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205552-001 7514444 2026-12-28 Drug substance, Drug product 2013-12-12 N205552-001 8476284 2026-12-28 U-1650 2013-12-12 N205552-001 8476284 2026-12-28 U-1946 2013-12-12 N205552-001 8497277 2026-12-28 U-1491 2013-12-12 N205552-001 8497277 2026-12-28 U-1650 2013-12-12 N205552-001 8497277 2026-12-28 U-1946 2013-12-12 N205552-001 8497277 2026-12-28 U-2241 2013-12-12 N205552-001 8497277 2026-12-28 U-2242 2013-12-12 N205552-001 8497277 2026-12-28 U-3422 2013-12-12 N205552-001 8697711 2026-12-28 Drug substance, Drug product 2014-05-13 N205552-001 8703780 2026-12-28 U-1491 2014-05-13 N205552-001 8735403 2026-12-28 Drug substance, Drug product 2014-06-18 N205552-001 8754091 2026-12-28 Drug product 2014-07-01 N205552-001 8952015 2026-12-28 U-1491 2017-09-01 N205552-001 8952015 2026-12-28 U-1650 2017-09-01 N205552-001 8952015 2026-12-28 U-1946 2017-09-01 N205552-001 8957079 2026-12-28 Drug substance, Drug product 2015-03-16 N205552-001 9181257 2026-12-28 Drug substance, Drug product 2015-12-08 N205552-001 8563563 2027-04-26 U-1491 2018-01-19 N205552-001 8563563 2027-04-26 U-1650 2018-01-19 N205552-001 8563563 2027-04-26 U-1946 2018-01-19 N205552-001 8563563 2027-04-26 U-2219 2018-01-19 N205552-001 7514444*PED 2027-06-28 Pediatric extension N205552-001 8476284*PED 2027-06-28 Pediatric extension N205552-001 8497277*PED 2027-06-28 Pediatric extension N205552-001 8697711*PED 2027-06-28 Pediatric extension N205552-001 8703780*PED 2027-06-28 Pediatric extension N205552-001 8735403*PED 2027-06-28 Pediatric extension N205552-001 8754091*PED 2027-06-28 Pediatric extension N205552-001 8952015*PED 2027-06-28 Pediatric extension N205552-001 8957079*PED 2027-06-28 Pediatric extension N205552-001 9181257*PED 2027-06-28 Pediatric extension N205552-001 8563563*PED 2027-10-26 Pediatric extension N205552-001 8008309 2027-11-13 Drug substance, Drug product 2013-12-12 N205552-001 8008309*PED 2028-05-13 Pediatric extension N205552-001 10004746 2031-06-03 U-1684 2018-07-16 N205552-001 10004746 2031-06-03 U-1946 2018-07-16 N205552-001 10004746 2031-06-03 U-2241 2018-07-16 N205552-001 10004746 2031-06-03 U-2242 2018-07-16 N205552-001 10016435 2031-06-03 U-1650 2018-08-03 N205552-001 10478439 2031-06-03 U-1650 2019-12-10 N205552-001 10478439 2031-06-03 U-1684 2019-12-10 N205552-001 10478439 2031-06-03 U-1946 2019-12-10 N205552-001 10478439 2031-06-03 U-2241 2019-12-10 N205552-001 10478439 2031-06-03 U-2242 2019-12-10 N205552-001 10478439 2031-06-03 U-2665 2019-12-10 N205552-001 10478439 2031-06-03 U-3422 2019-12-10 N205552-001 10751342 2031-06-03 U-1491 2020-09-10 N205552-001 10751342 2031-06-03 U-1946 2020-09-10 N205552-001 10751342 2031-06-03 U-2943 2020-09-10 N205552-001 10751342 2031-06-03 U-2944 2020-09-10 N205552-001 11672803 2031-06-03 U-1684 2023-07-14 N205552-001 11672803 2031-06-03 U-1946 2023-07-14 N205552-001 11672803 2031-06-03 U-2241 2023-07-14 N205552-001 11672803 2031-06-03 U-2242 2023-07-14 N205552-001 8999999 2031-06-03 U-1683 2015-04-28 N205552-001 8999999 2031-06-03 U-1684 2015-04-28 N205552-001 9125889 2031-06-03 U-1745 2015-09-25 N205552-001 9801881 2031-06-03 U-1491 2017-11-06 N205552-001 9801883 2031-06-03 U-2159 2017-11-06 N205552-001 10004746*PED 2031-12-03 Pediatric extension N205552-001 10016435*PED 2031-12-03 Pediatric extension N205552-001 10478439*PED 2031-12-03 Pediatric extension N205552-001 10751342*PED 2031-12-03 Pediatric extension N205552-001 8999999*PED 2031-12-03 Pediatric extension N205552-001 9125889*PED 2031-12-03 Pediatric extension N205552-001 9801881*PED 2031-12-03 Pediatric extension N205552-001 9801883*PED 2031-12-03 Pediatric extension N205552-001 10106548 2033-06-03 Drug substance, Drug product 2018-10-26 N205552-001 10125140 2033-06-03 Drug substance, Drug product 2018-11-16 N205552-001 10294231 2033-06-03 Drug product 2019-05-23 N205552-001 10294232 2033-06-03 Drug product 2019-05-23 N205552-001 10752634 2033-06-03 Drug product 2020-09-10 N205552-001 10961251 2033-06-03 Drug product 2021-04-16 N205552-001 9713617 2033-06-03 Drug product 2017-08-28 N205552-001 9725455 2033-06-03 Drug substance 2017-08-28 N205552-001 9540382 2033-08-18 U-1650 2017-01-30 N205552-001 9540382 2033-08-18 U-1684 2017-01-30 N205552-001 9540382 2033-08-18 U-1946 2017-01-30 N205552-001 9296753 2033-10-30 Drug substance, Drug product 2016-04-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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.
Product history page 1 of 3 · 84 observed 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 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205552-001 IMBRUVICA 140MG CAPSULE / ORAL RLD, RS 2013-11-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205552-002 IMBRUVICA 70MG CAPSULE / ORAL RLD 2017-12-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205552-001 AB 1 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205552-002 AB 1 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 192 · 7,659 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 N205552-001 7514444 2026-12-28 Drug substance, Drug product 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8476284 2026-12-28 U-1650 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8476284 2026-12-28 U-1946 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277 2026-12-28 U-1491 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277 2026-12-28 U-1946 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277 2026-12-28 U-2242 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277 2026-12-28 U-2241 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277 2026-12-28 U-3422 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277 2026-12-28 U-1650 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8697711 2026-12-28 Drug substance, Drug product 2014-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8703780 2026-12-28 U-1491 2014-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8735403 2026-12-28 Drug substance, Drug product 2014-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8754091 2026-12-28 Drug product 2014-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8952015 2026-12-28 U-1650 2017-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8952015 2026-12-28 U-1491 2017-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8952015 2026-12-28 U-1946 2017-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8957079 2026-12-28 Drug substance, Drug product 2015-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 9181257 2026-12-28 Drug substance, Drug product 2015-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8563563 2027-04-26 U-1946 2018-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8563563 2027-04-26 U-2219 2018-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8563563 2027-04-26 U-1650 2018-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8563563 2027-04-26 U-1491 2018-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 7514444*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8476284*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8497277*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8697711*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8703780*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8735403*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8754091*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8952015*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8957079*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 9181257*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8563563*PED 2027-10-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8008309 2027-11-13 Drug substance, Drug product 2013-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 8008309*PED 2028-05-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 10004746 2031-06-03 U-2242 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 10004746 2031-06-03 U-2241 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 10004746 2031-06-03 U-1946 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 10004746 2031-06-03 U-1684 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205552-001 10016435 2031-06-03 U-1650 2018-08-03 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 13 · 503 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/1
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 57962-070-28 Imbruvica 28 in 1 BOTTLE, PLASTIC CAPSULE 28 65
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57962-070 IMBRUVICA (IBRUTINIB) CAPSULE IMBRUVICA (IBRUTINIB) TABLET, FILM COATED IMBRUVICA (IBRUTINIB) SUSPENSION [PHARMACYCLICS LLC] 60 Current NDC, Legacy NDC, 1 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 Units Marketing start Marketing end Sample Exclude flag Status 57962-070-28 57962007028 28 CAPSULE in 1 BOTTLE, PLASTIC (57962-070-28) 28 capsule 2017-12-20 0000-00-00 No No Current