roduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57962-280
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBRUTINIB (UNII: 1X70OSD4VX) (IBRUTINIB - UNII:1X70OSD4VX) IBRUTINIB 280 mg
PRODUCT CHARACTERISTICS
Color PURPLE Score no score
Shape OVAL (Oblong) Size 15mm
Flavor Imprint Code ibr;280
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57962-280-28 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
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57962-420
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBRUTINIB (UNII: 1X70OSD4VX) (IBRUTINIB - UNII:1X70OSD4VX) IBRUTINIB 420 mg
PRODUCT CHARACTERISTICS
Color GREEN (Yellow-green to green) Score no score
Shape OVAL (Oblong) Size 18mm
Flavor Imprint Code ibr;420
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57962-420-28 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
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57962-560
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBRUTINIB (UNII: 1X70OSD4VX) (IBRUTINIB - UNII:1X70OSD4VX) IBRUTINIB 560 mg
PRODUCT CHARACTERISTICS
Color YELLOW (Yellow to orange) Score no score
Shape OVAL (Oblong) Size 19mm
Flavor Imprint Code ibr;560
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57962-560-28 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
LABELER - PHARMACYCLICS LLC (079857498)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Pharmacyclics LLC 079857498 ANALYSIS(57962-140, 57962 |
