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NDC 57894-0350-89 SIMPONI ARIA 50 mg/4mL Details
SIMPONI ARIA 50 mg/4mL
SIMPONI ARIA is a INTRAVENOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is GOLIMUMAB.
MedlinePlus Drug Summary
Golimumab injection (Simponi) is used 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) along with methotrexate (Otrexup, Rasuvo, Trexall) in adults, ankylosing spondylitis (condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults, psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) alone or in combination with methotrexate in adults, and ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) when other medications and treatments did not help or could not be tolerated. Golimumab injection (Simponi Aria) is also used to relieve the symptoms of certain autoimmune disorders including: rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) along with methotrexate (Otrexup, Rasuvo, Trexall) in adults, ankylosing spondylitis (condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults, psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults and children 2 years of age and older, polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age and older. Golimumab 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: 57894-0350-89Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Golimumab Injection
Product Information
NDC | 57894-0350 |
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Product ID | 57894-350_00d8fc3f-a495-cd29-e063-6294a90a976d |
Associated GPIs | 66270040002015 |
GCN Sequence Number | 071250 |
GCN Sequence Number Description | golimumab VIAL 50 MG/4 ML INTRAVEN |
HIC3 | S2J |
HIC3 Description | ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR |
GCN | 34983 |
HICL Sequence Number | 036278 |
HICL Sequence Number Description | GOLIMUMAB |
Brand/Generic | Brand |
Proprietary Name | SIMPONI ARIA |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | golimumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/4mL |
Substance Name | GOLIMUMAB |
Labeler Name | Janssen Biotech, Inc. |
Pharmaceutical Class | Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125433 |
Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0350-89 (57894035089)
NDC Package Code | 57894-350-89 |
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Billing NDC | 57894035089 |
Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE |
Marketing Start Date | 2013-07-19 |
NDC Exclude Flag | N |
Pricing Information | N/A |