DISPLAY PANEL - 28 Tablet Blister Strip (Back)
INGREDIENTS AND APPEARANCE
IMBRUVICA
ibrutinib capsule
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57962-070
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBRUTINIB (UNII: 1X70OSD4VX) (IBRUTINIB - UNII:1X70OSD4VX) IBRUTINIB 70 mg
PRODUCT CHARACTERISTICS
Color YELLOW Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ibr;70;mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57962-070-28 28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2017
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205552 12/20/2017
IMBRUVICA
ibrutinib capsule
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57962-140
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBRUTINIB (UNII: 1X70OSD4VX) (IBRUTINIB - UNII:1X70OSD4VX) IBRUTINIB 140 mg
PRODUCT CHARACTERISTICS
Color WHITE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code ibr;140;mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57962-140-09 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2013
2 NDC:57962-140-12 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2013
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205552 11/13/2013
IMBRUVICA
ibrutinib tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57962-014
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBRUTINIB (UNII: 1X70OSD4VX) (IBRUTINIB - UNII:1X70OSD4VX) IBRUTINIB 140 mg
PRODUCT CHARACTERISTICS
Color GREEN (Yellow-green to green) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code ibr;140
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57962-014-28 1 in 1 CARTON 02/16/2018
1 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210563 02/16/2018
IMBRUVICA
ibrutinib tablet, film coated
PRODUCT INFORMATION
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