Imprint Code
Contains
Packaging
NDC Package Description Multilevel Packaging
1 55513-221-01 1 VIAL In 1 CARTON contains a VIAL
1 5 mL In 1 VIAL This package is contained within the CARTON (55513-221-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125268 08/25/2008
NPLATE
romiplostim injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 55513-222
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
romiplostim (romiplostim) romiplostim 500 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
hydrochloric acid
HISTIDINE 10 mmol in 1 mL
MANNITOL 40 mg in 1 mL
POLYSORBATE 20 0.04 mg in 1 mL
sucrose 20 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
NDC Package Description Multilevel Packaging
1 55513-222-01 1 VIAL In 1 CARTON contains a VIAL
1 5 mL In 1 VIAL This package is contained within the CARTON (55513-222-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125268 08/25/2008
Labeler - Amgen, Inc. (039976196)
Registrant - Amgen, Inc. (039976196)
Establishment
Name Address ID/FEI Operations
Amgen, Inc. 039976196 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Amgen, Inc 048053201 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Amgen, Inc 071629633 ANALYSIS
Establishment
Name Address ID/FEI Operations
Amgen Europe BV 419643184 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A. 338336589 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Immunex Rhode Island Corporation 085509730 ANALYSIS
Establishment
Name Address ID/FEI Operations
Amgen Fremont Inc 960193530 ANALYSIS
Establishment
Name Address ID/FEI Operations
LANCASTER LABORATORIES INC 069777290 ANALYSIS
Establishment
Name Address ID/FEI Operations
NELSON LABORATORIES, INC. 151663234 ANALYSIS
Establishment
Name Address ID/FEI Operations
NORTH AMERICAN SCIENCE ASSOCIATES INC 063722102 ANALYSIS
Revised: 01/2011Amgen, Inc.
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