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pegfilgrastim kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-192
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55513-192-01 1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 0.6 mL
Part 1 of 1
NEULASTA
pegfilgrastim injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEGFILGRASTIM (UNII: 3A58010674) (PEGFILGRASTIM - UNII:3A58010674) PEGFILGRASTIM 6 mg in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID (UNII: Q40Q9N063P) 0.35 mg in 0.6 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.02 mg in 0.6 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R) 30.0 mg in 0.6 mL
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 0.6 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 BLA125031 04/01/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125031 04/01/2002
NEULASTA
pegfilgrastim injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-190
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEGFILGRASTIM (UNII: 3A58010674) (PEGFILGRASTIM - UNII:3A58010674) PEGFILGRASTIM 6 mg in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID (UNII: Q40Q9N063P) 0.35 mg in 0.6 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.02 mg in 0.6 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R) 30.0 mg in 0.6 mL
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55513-190-01 1 in 1 CARTON
1 0.6 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 BLA125031 04/01/2002
Labeler - Amgen Inc (039976196)
Establishment
Name Address ID/FEI Business Operations
Amgen Manufacturing Ltd 785800020 ANALYSIS(55513-190, 55513-192) , LABEL(55513-192, 55513-190) , MANUFACTURE(55513-190, 55513-192) , PACK(55513-192, 55513-190
