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NDC 58406-0044-96 ENBREL 50 mg/mL Details
ENBREL 50 mg/mL
ENBREL is a SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Immunex Corporation. The primary component is ETANERCEPT.
MedlinePlus Drug Summary
Etanercept injection products are used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including: rheumatoid arthritis (condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults, psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults, juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) in children 2 years of age and older, ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage), chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults and children 4 years of age and older whose psoriasis is too severe to be treated by topical medications alone. Etanercept is in a class of medications called tumor-necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation
Related Packages: 58406-0044-96Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Etanercept Injection
Product Information
NDC | 58406-0044 |
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Product ID | 58406-044_29187b7c-d166-45e4-bc8c-4cbf71a67702 |
Associated GPIs | |
GCN Sequence Number | 077783 |
GCN Sequence Number Description | etanercept CARTRIDGE 50MG/ML(1) SUBCUT |
HIC3 | S2J |
HIC3 Description | ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR |
GCN | 43924 |
HICL Sequence Number | 018830 |
HICL Sequence Number Description | ETANERCEPT |
Brand/Generic | Brand |
Proprietary Name | ENBREL |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | etanercept |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/mL |
Substance Name | ETANERCEPT |
Labeler Name | Immunex Corporation |
Pharmaceutical Class | Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA103795 |
Listing Certified Through | 2024-12-31 |
Package
NDC 58406-0044-96 (58406004496)
NDC Package Code | 58406-044-96 |
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Billing NDC | 58406004496 |
Package | 1 CARTRIDGE in 1 CARTON (58406-044-96) / 1 mL in 1 CARTRIDGE |
Marketing Start Date | 2019-06-07 |
NDC Exclude Flag | N |
Pricing Information | N/A |