e Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETANERCEPT (ETANERCEPT) ETANERCEPT 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE HYDROCHLORIDE 0.025 mmol in 1 mL
SODIUM CHLORIDE 0.1 mmol in 1 mL
SODIUM PHOSPHATE 0.025 mmol in 1 mL
SUCROSE 10 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 58406-445-04 4 SYRINGE In 1 CARTON contains a SYRINGE (58406-445-01)
1 58406-445-01 1 mL In 1 SYRINGE This package is contained within the CARTON (58406-445-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795 11/10/2005
ENBREL
etanercept kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58406-425
Packaging
# NDC Package Description Multilevel Packaging
1 58406-425-34 4 KIT In 1 CARTON contains a KIT (58406-425-41)
1 58406-425-41 1 KIT In 1 KIT This package is contained within the CARTON (58406-425-34)
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 1 mL
Part 2 1 VIAL 1 mL
Part 1 of 2
STERILE BACTERIOSTATIC WATER FOR INJECTION
sterile bacteriostatic water for injection solution
Product Information
NDC Product Code (Source) 58406-910
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZYL ALCOHOL (BENZYL ALCOHOL) BENZYL ALCOHOL 9.93 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER 1 mL in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 58406-910-01 1 mL In 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795
Part 2 of 2
ENBREL
etanercept injection, powder, lyophilized, for solution
Product Information
NDC Product Code (Source) 58406-425
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETANERCEPT (ETANERCEPT) ETANERCEPT 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 40 mg in 1 mL
SUCROSE 10 mg in 1 mL
TROMETHAMINE 1.2 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 58406-425-01 1 mL In 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795 01/02 |
