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NDC 00069-0238-01 Ruxience 100 mg/10mL Details
Ruxience 100 mg/10mL
Ruxience is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is RITUXIMAB.
MedlinePlus Drug Summary
Rituximab injection products are used in adults alone or with other medications to treat various types of non-Hodgkin's lymphoma (NHL; a type of cancer that begins in a type of white blood cells that normally fights infection). Rituximab injection products are also used in adults with other medications to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Rituximab injection products (Rituxan, Ruxience, Truxima) are also used in adults with methotrexate (Otrexup, Rasuvo, Xatmep, others) to treat the symptoms of rheumatoid arthritis (RA; a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults who have already been treated with a certain type of medication called a tumor necrosis factor (TNF) inhibitor. Rituximab injection products (Rituxan, Riabni, Ruxience, Truxima) are also used in adults and children 2 years of age and older along with other medications to treat granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis, which are conditions in which the body attacks its own veins and other blood vessels, which causes damage to organs, such as the heart and lungs. Rituximab injection (Rituxan) is used to treat pemphigus vulgaris (a condition that causes painful blisters on the skin and the lining the mouth, nose, throat and genitals). Rituximab injection products are in a class of medications called monoclonal antibodies. They treat the various types of NHL and CLL by killing cancer cells. Certain rituximab injection products also treat rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris by blocking the activity of the part of the immune system that may damage the joints, veins, and other blood vessels.
Related Packages: 00069-0238-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Rituximab Injection
Product Information
NDC | 00069-0238 |
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Product ID | 0069-0238_7b46204f-1661-40a2-8926-3811582bebe0 |
Associated GPIs | 21351860602020 |
GCN Sequence Number | 080059 |
GCN Sequence Number Description | rituximab-pvvr VIAL 10 MG/ML INTRAVEN |
HIC3 | Z2W |
HIC3 Description | ANTI-CD20 (B LYMPHOCYTE) MONOCLONAL ANTIBODY |
GCN | 46734 |
HICL Sequence Number | 045899 |
HICL Sequence Number Description | RITUXIMAB-PVVR |
Brand/Generic | Brand |
Proprietary Name | Ruxience |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | rituximab-pvvr |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/10mL |
Substance Name | RITUXIMAB |
Labeler Name | Pfizer Laboratories Div Pfizer Inc |
Pharmaceutical Class | CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761103 |
Listing Certified Through | 2025-12-31 |
Package
NDC 00069-0238-01 (00069023801)
NDC Package Code | 0069-0238-01 |
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Billing NDC | 00069023801 |
Package | 1 VIAL, SINGLE-USE in 1 CARTON (0069-0238-01) / 10 mL in 1 VIAL, SINGLE-USE |
Marketing Start Date | 2020-01-23 |
NDC Exclude Flag | N |
Pricing Information | N/A |