Imbruvica

Product NDC
57962-140
11-digit product format
579620140
Labeler code
57962
Product ID
57962-140_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
2013-11-13
Substance
IBRUTINIB
Active strength
140 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205552-001IMBRUVICAIBRUTINIB140MGCAPSULE / ORALRLD, RS2013-11-13
N205552-002IMBRUVICAIBRUTINIB70MGCAPSULE / ORALRLD2017-12-20

Orange Book patents#

Current patent rows page 1 of 3 · 196 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205552-00175144442026-12-28Drug substance, Drug product2013-12-12
N205552-00184762842026-12-28U-16502013-12-12
N205552-00184762842026-12-28U-19462013-12-12
N205552-00184972772026-12-28U-14912013-12-12
N205552-00184972772026-12-28U-16502013-12-12
N205552-00184972772026-12-28U-19462013-12-12
N205552-00184972772026-12-28U-22412013-12-12
N205552-00184972772026-12-28U-22422013-12-12
N205552-00184972772026-12-28U-34222013-12-12
N205552-00186977112026-12-28Drug substance, Drug product2014-05-13
N205552-00187037802026-12-28U-14912014-05-13
N205552-00187354032026-12-28Drug substance, Drug product2014-06-18
N205552-00187540912026-12-28Drug product2014-07-01
N205552-00189520152026-12-28U-14912017-09-01
N205552-00189520152026-12-28U-16502017-09-01
N205552-00189520152026-12-28U-19462017-09-01
N205552-00189570792026-12-28Drug substance, Drug product2015-03-16
N205552-00191812572026-12-28Drug substance, Drug product2015-12-08
N205552-00185635632027-04-26U-14912018-01-19
N205552-00185635632027-04-26U-16502018-01-19
N205552-00185635632027-04-26U-19462018-01-19
N205552-00185635632027-04-26U-22192018-01-19
N205552-0017514444*PED2027-06-28Pediatric extension
N205552-0018476284*PED2027-06-28Pediatric extension
N205552-0018497277*PED2027-06-28Pediatric extension
N205552-0018697711*PED2027-06-28Pediatric extension
N205552-0018703780*PED2027-06-28Pediatric extension
N205552-0018735403*PED2027-06-28Pediatric extension
N205552-0018754091*PED2027-06-28Pediatric extension
N205552-0018952015*PED2027-06-28Pediatric extension
N205552-0018957079*PED2027-06-28Pediatric extension
N205552-0019181257*PED2027-06-28Pediatric extension
N205552-0018563563*PED2027-10-26Pediatric extension
N205552-00180083092027-11-13Drug substance, Drug product2013-12-12
N205552-0018008309*PED2028-05-13Pediatric extension
N205552-001100047462031-06-03U-16842018-07-16
N205552-001100047462031-06-03U-19462018-07-16
N205552-001100047462031-06-03U-22412018-07-16
N205552-001100047462031-06-03U-22422018-07-16
N205552-001100164352031-06-03U-16502018-08-03
N205552-001104784392031-06-03U-16502019-12-10
N205552-001104784392031-06-03U-16842019-12-10
N205552-001104784392031-06-03U-19462019-12-10
N205552-001104784392031-06-03U-22412019-12-10
N205552-001104784392031-06-03U-22422019-12-10
N205552-001104784392031-06-03U-26652019-12-10
N205552-001104784392031-06-03U-34222019-12-10
N205552-001107513422031-06-03U-14912020-09-10
N205552-001107513422031-06-03U-19462020-09-10
N205552-001107513422031-06-03U-29432020-09-10
N205552-001107513422031-06-03U-29442020-09-10
N205552-001116728032031-06-03U-16842023-07-14
N205552-001116728032031-06-03U-19462023-07-14
N205552-001116728032031-06-03U-22412023-07-14
N205552-001116728032031-06-03U-22422023-07-14
N205552-00189999992031-06-03U-16832015-04-28
N205552-00189999992031-06-03U-16842015-04-28
N205552-00191258892031-06-03U-17452015-09-25
N205552-00198018812031-06-03U-14912017-11-06
N205552-00198018832031-06-03U-21592017-11-06
N205552-00110004746*PED2031-12-03Pediatric extension
N205552-00110016435*PED2031-12-03Pediatric extension
N205552-00110478439*PED2031-12-03Pediatric extension
N205552-00110751342*PED2031-12-03Pediatric extension
N205552-0018999999*PED2031-12-03Pediatric extension
N205552-0019125889*PED2031-12-03Pediatric extension
N205552-0019801881*PED2031-12-03Pediatric extension
N205552-0019801883*PED2031-12-03Pediatric extension
N205552-001101065482033-06-03Drug substance, Drug product2018-10-26
N205552-001101251402033-06-03Drug substance, Drug product2018-11-16
N205552-001102942312033-06-03Drug product2019-05-23
N205552-001102942322033-06-03Drug product2019-05-23
N205552-001107526342033-06-03Drug product2020-09-10
N205552-001109612512033-06-03Drug product2021-04-16
N205552-00197136172033-06-03Drug product2017-08-28
N205552-00197254552033-06-03Drug substance2017-08-28
N205552-00195403822033-08-18U-16502017-01-30
N205552-00195403822033-08-18U-16842017-01-30
N205552-00195403822033-08-18U-19462017-01-30
N205552-00192967532033-10-30Drug substance, Drug product2016-04-18

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N205552-001NPP2025-08-24
N205552-001PED2026-02-24
N205552-001ODE-4052029-08-24
N205552-001PED2030-02-24
N205552-002NPP2025-08-24
N205552-002PED2026-02-24
N205552-002ODE-4052029-08-24
N205552-002PED2030-02-24

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205552-001IMBRUVICA140MGCAPSULE / ORALRLD, RS2013-11-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N205552-002IMBRUVICA70MGCAPSULE / ORALRLD2017-12-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205552-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205552-002AB187673890dc5c…

Observed Orange Book patent history#

Patent history page 1 of 192 · 7,659 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N205552-00175144442026-12-28Drug substance, Drug product2013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184762842026-12-28U-16502013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184762842026-12-28U-19462013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184972772026-12-28U-14912013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184972772026-12-28U-19462013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184972772026-12-28U-22422013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184972772026-12-28U-22412013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184972772026-12-28U-34222013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00184972772026-12-28U-16502013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00186977112026-12-28Drug substance, Drug product2014-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00187037802026-12-28U-14912014-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00187354032026-12-28Drug substance, Drug product2014-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00187540912026-12-28Drug product2014-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00189520152026-12-28U-16502017-09-01caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00189520152026-12-28U-14912017-09-01caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00189520152026-12-28U-19462017-09-01caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00189570792026-12-28Drug substance, Drug product2015-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00191812572026-12-28Drug substance, Drug product2015-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00185635632027-04-26U-19462018-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00185635632027-04-26U-22192018-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00185635632027-04-26U-16502018-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00185635632027-04-26U-14912018-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0017514444*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018476284*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018497277*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018697711*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018703780*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018735403*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018754091*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018952015*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018957079*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0019181257*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018563563*PED2027-10-26Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-00180083092027-11-13Drug substance, Drug product2013-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-0018008309*PED2028-05-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001100047462031-06-03U-22422018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001100047462031-06-03U-22412018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001100047462031-06-03U-19462018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001100047462031-06-03U-16842018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001100164352031-06-03U-16502018-08-03caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 13 · 503 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N205552-001NPP2025-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001PED2026-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001ODE-4052029-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-001PED2030-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-002NPP2025-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-002PED2026-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-002ODE-4052029-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07N205552-002PED2030-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205552-001NPP2025-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-001PED2026-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-001ODE-4052029-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-001PED2030-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-002NPP2025-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-002PED2026-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-002ODE-4052029-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205552-002PED2030-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001ODE-1522024-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001PED2025-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001M-142025-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001NPP2025-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001PED2026-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001ODE-4052029-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-001PED2030-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-002M-142025-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-002NPP2025-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-002PED2026-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-002ODE-4052029-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205552-002PED2030-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205552-001ODE-1522024-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-001PED2025-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-001M-142025-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-001NPP2025-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-001PED2026-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-001ODE-4052029-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-001PED2030-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-002M-142025-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-002NPP2025-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-002PED2026-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-002ODE-4052029-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205552-002PED2030-02-246a471c1ec25d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBRUTINIB140 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1X70OSD4VXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442986Internal RxNorm lookup
1442992Internal RxNorm lookup
1994360Internal RxNorm lookup
1994362Internal RxNorm lookup
2000017Internal RxNorm lookup
2000019Internal RxNorm lookup
2000021Internal RxNorm lookup
2000023Internal RxNorm lookup
2000025Internal RxNorm lookup
2000027Internal RxNorm lookup
2611536Internal RxNorm lookup
2611540Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0dfd0279-ff17-4ea9-89be-9803c71bab44Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5f848317-6ae0-42d3-a6bc-cc4cde817084Product name420230426
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57962-140-092025-08-04These 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
57962-140-092025-08-04These 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
57962-140-092025-08-04These 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
57962-140-122025-08-04These 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
57962-140-122025-08-04These 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
57962-140-122025-08-04These 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
57962-140-092025-07-29These 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
57962-140-092025-07-29These 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
57962-140-092025-07-29These 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
57962-140-122025-07-29These 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
57962-140-122025-07-29These 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
57962-140-122025-07-29These 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 NDCProductDescriptionFormQuantityStrengthSPL version
57962-140-09Imbruvica90 in 1 BOTTLE, PLASTICCAPSULE9065
57962-140-12Imbruvica120 in 1 BOTTLE, PLASTICCAPSULE12065

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57962-140-09EA - Each57962-140587eae82-c6db-45d6-8c50-006ec7653fee12013-12-02
57962-140-12EA - Each57962-14053ded19e-23f3-48dc-bd76-3638053e06e912013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbrutinibACTIVE INGREDIENT1X70OSD4VXIMBRUVICA (IBRUTINIB) CAPSULE [PHARMACYCLICS, INC]6
IbrutinibACTIVE MOIETY1X70OSD4VXIMBRUVICA (IBRUTINIB) CAPSULE [PHARMACYCLICS, INC]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIMBRUVICA (IBRUTINIB) CAPSULE [PHARMACYCLICS, INC]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IMBRUVICA (IBRUTINIB) CAPSULE [PHARMACYCLICS, INC]6
Magnesium stearateINACTIVE INGREDIENT70097M6I30IMBRUVICA (IBRUTINIB) CAPSULE [PHARMACYCLICS, INC]6
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JIMBRUVICA (IBRUTINIB) CAPSULE [PHARMACYCLICS, INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57962-140IMBRUVICA (IBRUTINIB) CAPSULE IMBRUVICA (IBRUTINIB) TABLET, FILM COATED IMBRUVICA (IBRUTINIB) SUSPENSION [PHARMACYCLICS LLC]60Current NDC, Legacy NDC, 2 package rows20250309_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ImbruvicaIBRUTINIBPharmacyclics LLC0dfd0279-ff17-4ea9-89be-9803c71bab442025-10-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 205552
application number: NDA205552
ndc (product): 57962-140

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442986ibrutinib 140 MG Oral CapsulePSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000017ibrutinib 140 MG Oral TabletPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000021ibrutinib 280 MG Oral TabletPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000025ibrutinib 420 MG Oral TabletPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
1994360ibrutinib 70 MG Oral CapsulePSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2611536ibrutinib 70 MG/mL Oral SuspensionPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
1442992Imbruvica 140 MG Oral CapsulePSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000019Imbruvica 140 MG Oral TabletPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000023Imbruvica 280 MG Oral TabletPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000027Imbruvica 420 MG Oral TabletPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
1994362Imbruvica 70 MG Oral CapsulePSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
2611540Imbruvica 70 MG/mL Oral SuspensionPSN0dfd0279-ff17-4ea9-89be-9803c71bab4465
1442992ibrutinib 140 MG Oral Capsule [Imbruvica]SBD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000019ibrutinib 140 MG Oral Tablet [Imbruvica]SBD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000023ibrutinib 280 MG Oral Tablet [Imbruvica]SBD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000027ibrutinib 420 MG Oral Tablet [Imbruvica]SBD0dfd0279-ff17-4ea9-89be-9803c71bab4465
1994362ibrutinib 70 MG Oral Capsule [Imbruvica]SBD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2611540ibrutinib 70 MG/ML Oral Suspension [Imbruvica]SBD0dfd0279-ff17-4ea9-89be-9803c71bab4465
1442986ibrutinib 140 MG Oral CapsuleSCD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000017ibrutinib 140 MG Oral TabletSCD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000021ibrutinib 280 MG Oral TabletSCD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000025ibrutinib 420 MG Oral TabletSCD0dfd0279-ff17-4ea9-89be-9803c71bab4465
1994360ibrutinib 70 MG Oral CapsuleSCD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2611536ibrutinib 70 MG/ML Oral SuspensionSCD0dfd0279-ff17-4ea9-89be-9803c71bab4465
2611536ibrutinib 70 MG/ML Oral SuspensionSY0dfd0279-ff17-4ea9-89be-9803c71bab4465
1442992Imbruvica 140 MG Oral CapsuleSY0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000019Imbruvica 140 MG Oral TabletSY0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000023Imbruvica 280 MG Oral TabletSY0dfd0279-ff17-4ea9-89be-9803c71bab4465
2000027Imbruvica 420 MG Oral TabletSY0dfd0279-ff17-4ea9-89be-9803c71bab4465
1994362Imbruvica 70 MG Oral CapsuleSY0dfd0279-ff17-4ea9-89be-9803c71bab4465
2611540Imbruvica 70 MG/ML Oral SuspensionSY0dfd0279-ff17-4ea9-89be-9803c71bab4465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57962-140-095796201400990 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-09) 90 capsule2013-11-130000-00-00NoNoCurrent
57962-140-1257962014012120 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-12) 120 capsule2013-11-130000-00-00NoNoCurrent