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NDC 00003-3774-12 OPDIVO 10 mg/mL Details
OPDIVO 10 mg/mL
OPDIVO is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E.R. Squibb & Sons, L.L.C.. The primary component is NIVOLUMAB.
MedlinePlus Drug Summary
Nivolumab injection is used: alone or in combination with ipilimumab (Yervoy) to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery, to treat and prevent the return of a certain type of melanoma after surgery to remove it and any affected tissue and lymph nodes, in combination with ipilimumab (Yervoy) or with ipilimumab and platinum-containing chemotherapy as an initial treatment for a certain type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body or returned. Also used in combination with platinum-containing chemotherapy before surgery to treat a certain type of NSCLC, alone to treat a certain type of NSCLC that has spread to other parts of the body and has worsened either during or after treatment with platinum-containing chemotherapy, to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys) that worsened after treatment with other chemotherapy medications, in combination with ipilimumab (Yervoy) or with cabozantinib (Cabometryx, Cometriq) to treat advanced RCC in people who have not been treated with other chemotherapy medications, to treat Hodgkin's lymphoma (Hodgkin's disease) in adults who worsened or did not respond to autologous stem cell transplant (procedure in which certain blood cells are removed from the body and then returned to the body after chemotherapy and/or radiation treatment) and brentuximab vedotin (Adcetris) treatment or at least three other treatments including the stem cell transplant, to treat a certain type of head and neck cancer that keeps coming back or that has spread to other parts of the body or worsened during or after treatment with platinum-containing chemotherapy, to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to other parts of the body and has worsened during or after treatment with platinum-containing chemotherapy. It is also used after surgery to remove urothelial cancer, to reduce the risk of the cancer coming back. alone or in combination with ipilimumab to treat a certain type of colorectal cancer (cancer that begins in the large intestine) in adults and children 12 years of age and older that has spread to other parts of the body and has worsened after treatment with other chemotherapy medications, in combination with ipilimumab to treat hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated with sorafenib (Nexafar), to treat and prevent the return of a certain type of esophageal cancer (cancer of the tube that connects your throat to your stomach) after chemotherapy and/or radiation treatment and surgery to remove it and any affected tissue and lymph nodes, alone to treat a certain type of esophageal cancer that cannot be removed by surgery and has spread to other parts of the body or has worsened after treatment with other chemotherapy medications. It can also be used in combination with ipilimumab or with fluorouracil and a platinum-containing chemotherapy medication to treat certain types of esophageal cancer that cannot be removed by surgery and that has spread to other parts of the body or has worsened after treatment with other chemotherapy medications, in combination with fluorouracil and a platinum-containing chemotherapy medication to treat certain types of gastric cancer (cancer of the stomach) or gastroesophageal junction cancer (cancer located in the area where the stomach meets the esophagus) that has spread to other parts of the body, and in combination with ipilimumab as an initial treatment for malignant pleural mesothelioma (a type of cancer that affects the inside lining of the lungs and chest cavity) in adults that cannot be removed by surgery. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.
Related Packages: 00003-3774-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nivolumab Injection
Product Information
NDC | 00003-3774 |
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Product ID | 0003-3774_14db8181-5332-4374-8278-53b726994528 |
Associated GPIs | 21357941002030 |
GCN Sequence Number | 073249 |
GCN Sequence Number Description | nivolumab VIAL 100MG/10ML INTRAVEN |
HIC3 | V3R |
HIC3 Description | ANTINEOPLASTIC,ANTI-PROGRAMMED DEATH-1 (PD-1) MAB |
GCN | 37627 |
HICL Sequence Number | 041654 |
HICL Sequence Number Description | NIVOLUMAB |
Brand/Generic | Brand |
Proprietary Name | OPDIVO |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | nivolumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/mL |
Substance Name | NIVOLUMAB |
Labeler Name | E.R. Squibb & Sons, L.L.C. |
Pharmaceutical Class | Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125554 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00003-3774-12 (00003377412)
NDC Package Code | 0003-3774-12 |
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Billing NDC | 00003377412 |
Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3774-12) / 10 mL in 1 VIAL, SINGLE-DOSE |
Marketing Start Date | 2014-12-22 |
NDC Exclude Flag | N |
Pricing Information | N/A |