ENBREL (Page 16 of 16)

etanercept

Label ImageLabel Image
ENBREL etanercept solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3531(NDC:58406-445)
Route of Administration SUBCUTANEOUS DEA Schedule
Active 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 0.12 mmol in 1 mL
SUCROSE 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3531-0 1 mL in 1 KIT None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795 11/10/2005
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3531)

Revised: 06/2021 A-S Medication Solutions

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