ration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Venetoclax (UNII: N54AIC43PW) (Venetoclax - UNII:N54AIC43PW) Venetoclax 100 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 OVAL (oblong, biconvex) Size 17mm
Flavor Imprint Code V;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7 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
Part 4 of 4
VENCLEXTA
venetoclax tablet, film coated
Product Information
Item Code (Source) NDC:0074-0576
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Venetoclax (UNII: N54AIC43PW) (Venetoclax - UNII:N54AIC43PW) Venetoclax 100 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)
TIT
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 14 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
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:0074-0576
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Venetoclax (UNII: N54AIC43PW) (Venetoclax - UNII:N54AIC43PW) Venetoclax 100 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
ANHYDROU |
