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NDC 78206-0162-01 Renflexis 100 mg/1 Details
Renflexis 100 mg/1
Renflexis is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Organon LLC. The primary component is INFLIXIMAB.
MedlinePlus Drug Summary
Infliximab injection products are 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 (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) that is also being treated with methotrexate (Rheumatrex, Trexall), Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults and children 6 years of age or older that has not improved when treated with other medications, ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) in adults and children 6 years of age or older that has not improved when treated with other medications, ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage), plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults when other treatments are less appropriate, and psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin). Infliximab injection products are in a class of medications called tumor necrosis factor-alpha (TNF-alpha) inhibitors. They work by blocking the action of TNF-alpha, a substance in the body that causes inflammation.
Related Packages: 78206-0162-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Infliximab Injection
Product Information
| NDC | 78206-0162 |
|---|---|
| Product ID | 78206-162_7437432c-e2d3-4be0-847d-fdcd176ce304 |
| Associated GPIs | 52505040102120 |
| GCN Sequence Number | 077588 |
| GCN Sequence Number Description | infliximab-abda VIAL 100 MG INTRAVEN |
| HIC3 | S2J |
| HIC3 Description | ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR |
| GCN | 43638 |
| HICL Sequence Number | 044432 |
| HICL Sequence Number Description | INFLIXIMAB-ABDA |
| Brand/Generic | Brand |
| Proprietary Name | Renflexis |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | infliximab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | INFLIXIMAB |
| Labeler Name | Organon LLC |
| Pharmaceutical Class | Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761054 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 78206-0162-01 (78206016201)
| NDC Package Code | 78206-162-01 |
|---|---|
| Billing NDC | 78206016201 |
| Package | 1 VIAL in 1 CARTON (78206-162-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99) |
| Marketing Start Date | 2021-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |