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ustekinumab (UNII: FU77B4U5Z0) (ustekinumab - UNII:FU77B4U5Z0) ustekinumab 130 mg in 26 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
Edetate Disodium (UNII: 7FLD91C86K) 0.52 mg in 26 mL
Histidine (UNII: 4QD397987E) 20 mg in 26 mL
Histidine Monohydrochloride Monohydrate (UNII: X573657P6P) 27 mg in 26 mL
Methionine (UNII: AE28F7PNPL) 10.4 mg in 26 mL
Polysorbate 80 (UNII: 6OZP39ZG8H) 10.4 mg in 26 mL
Sucrose (UNII: C151H8M554) 2210 mg in 26 mL
PRODUCT CHARACTERISTICS
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57894-054-27 1 in 1 BOX 09/23/2016
1 26 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2 NDC:57894-054-16 1 in 1 BOX 05/01/2017
2 26 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761044 09/23/2016
LABELER - JANSSEN BIOTECH, INC. (099091753)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Patheon Biologics LLC 965750420 API MANUFACTURE(57894-060, 57894-061) , ANALYSIS(57894-060, 57894-061)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Cilag AG 483237103 MANUFACTURE(57894-060, 57894-061, 57894-054) , ANALYSIS(57894-060, 57894-061, 57894-054)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Janssen Biologics B.V. 409612918 ANALYSIS(57894-060, 57894-061, 57894-054) , API MANUFACTURE(57894-060, 57894-061, 57894-054)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Baxter Pharmaceutical Solutions 604719430 MANUFACTURE(57894-060, 57894-061)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Janssen Sciences Ireland UC 986030167 API MANUFACTURE(57894-060, 57894-061, 57894-054) , ANALYSIS(57894-060, 57894-061, 57894-054)
ESTABLISHMENT
Name Address ID/FEI Business Operations
PPD Development Ireland Ltd. 985036175 ANALYSIS(57894-054)
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