FDA.reportPublic FDA data

Imbruvica

Product NDC
57962-014
11-digit product format
579620014
Labeler code
57962
Product ID
57962-014_43280dcb-52ae-40e4-bd52-723f71f74ab7
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
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

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 Identifiers#

Field, Values table
FieldValues
Unii1X70OSD4VX
Rxcui1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023, 2000025, 2000027, 2611536, 2611540

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57962-014-282025-08-04C16284748780-13b156c62-28c7-fb37-e063-e6dba90a4e07These 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
57962-014-282025-08-04C16284748780-13b156c62-28c7-fb37-e063-e6dba90a4e07These 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
57962-014-282025-08-04C16284748780-13b156c62-28c7-fb37-e063-e6dba90a4e07These 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
57962-014-282025-07-29C16284748780-13b156c62-28c7-fb37-e063-e6dba90a4e07These 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
57962-014-282025-07-29C16284748780-13b156c62-28c7-fb37-e063-e6dba90a4e07These 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
57962-014-282025-07-29C16284748780-13b156c62-28c7-fb37-e063-e6dba90a4e07These 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
57962-014-28Imbruvica1 in 1 CARTONTABLET, FILM COATED165
57962-014-28Imbruvica28 in 1 BLISTER PACKTABLET, FILM COATED2865

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57962-014IMBRUVICA (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

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
57962-014-28579620014281 BLISTER PACK in 1 CARTON (57962-014-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-02-160000-00-00NoNoCurrent