e) NDC:57894-060
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
ustekinumab (UNII: FU77B4U5Z0) (ustekinumab - UNII:FU77B4U5Z0) ustekinumab 45 mg in 0.5 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
sucrose (UNII: C151H8M554) 38 mg in 0.5 mL
polysorbate 80 (UNII: 6OZP39ZG8H) 0.02 mg in 0.5 mL
HISTIDINE (UNII: 4QD397987E) 0.5 mg in 0.5 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (UNII: X573657P6P)
water (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57894-060-02 1 in 1 CARTON 09/25/2009
1 0.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2 NDC:57894-060-03 1 in 1 CARTON 09/25/2009
2 0.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3 NDC:57894-060-04 1 in 1 CARTON 09/25/2009
3 0.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125261 09/25/2009
STELARA
ustekinumab injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-061
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
ustekinumab (UNII: FU77B4U5Z0) (ustekinumab - UNII:FU77B4U5Z0) ustekinumab 90 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
sucrose (UNII: C151H8M554) 76 mg in 1 mL
polysorbate 80 (UNII: 6OZP39ZG8H) 0.04 mg in 1 mL
HISTIDINE (UNII: 4QD397987E) 1 mg in 1 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (UNII: X573657P6P)
water (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57894-061-02 1 in 1 CARTON 09/25/2009
1 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2 NDC:57894-061-03 1 in 1 CARTON 09/25/2009
2 1 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3 NDC:57894-061-04 1 in 1 CARTON 09/25/2009
3 1 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125261 09/25/2009
STELARA
ustekinumab solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-054
Route of Administration INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Streng |
