S DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
Talc (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape OVAL (oblong, biconvex) Size 17mm
Flavor Imprint Code V;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0074-0576-22 120 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2016
2 NDC:0074-0576-11 1 in 1 CARTON 04/11/2016
2 1 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 NDA208573 04/11/2016
VENCLEXTA
venetoclax tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-0561
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Venetoclax (UNII: N54AIC43PW) (Venetoclax - UNII:N54AIC43PW) Venetoclax 10 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
Talc (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape ROUND (round, biconvex) Size 6mm
Flavor Imprint Code V;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0074-0561-14 1 in 1 CARTON 04/11/2016
1 14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0074-0561-11 1 in 1 CARTON 04/11/2016
2 2 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 NDA208573 04/11/2016
VENCLEXTA
venetoclax tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-0566
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Venetoclax (UNII: N54AIC43PW) (Venetoclax - UNII:N54AIC43PW) Venetoclax 50 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) &nbs |
