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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57962-560-28EA - Each57962-56056d0193b-907e-4d3a-8e0f-fb58bb4e86d312018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57962-560-28579620560281 BLISTER PACK in 1 CARTON (57962-560-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-02-160000-00-00NoNoCurrent