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NDC 00078-0669-13 ARZERRA 20 mg/mL Details
ARZERRA 20 mg/mL
ARZERRA is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is OFATUMUMAB.
MedlinePlus Drug Summary
Ofatumumab injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells): in combination with chlorambucil in people who have not received treatment or are unable to receive treatment with fludarabine (Fludara). in combination with fludarabine (Fludara) and alemtuzumab (Campath) when CLL has returned after previous treatment. as extended treatment in people with CLL that has improved fully or partially after at least two lines of treatment. in people who have not responded to treatment with fludarabine (Fludara) and alemtuzumab (Campath). Ofatumumab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells. Ofatumumab is also available as an injection (Kesimpta) that is used to treat multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). This monograph only gives information about ofatumumab injection (Arzerra) for treatment of chronic lymphocytic leukemia. If you are receiving ofatumumab for multiple sclerosis, read the monograph entitled Ofatumumab Injection (Multiple Sclerosis).
Related Packages: 00078-0669-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ofatumumab Injection (Chronic Lymphocytic Leukemia)
Product Information
NDC | 00078-0669 |
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Product ID | 0078-0669_1358cb68-5521-4de1-9749-5ed66f293d3b |
Associated GPIs | 21351845001320 |
GCN Sequence Number | 065775 |
GCN Sequence Number Description | ofatumumab VIAL 100 MG/5ML INTRAVEN |
HIC3 | Z2W |
HIC3 Description | ANTI-CD20 (B LYMPHOCYTE) MONOCLONAL ANTIBODY |
GCN | 27827 |
HICL Sequence Number | 036708 |
HICL Sequence Number Description | OFATUMUMAB |
Brand/Generic | Brand |
Proprietary Name | ARZERRA |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ofatumumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 20 |
Active Ingredient Units | mg/mL |
Substance Name | OFATUMUMAB |
Labeler Name | Novartis Pharmaceuticals Corporation |
Pharmaceutical Class | CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125326 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0669-13 (00078066913)
NDC Package Code | 0078-0669-13 |
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Billing NDC | 00078066913 |
Package | 3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61) |
Marketing Start Date | 2016-02-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |