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NDC 00003-2328-22 YERVOY 5 mg/mL Details
YERVOY 5 mg/mL
YERVOY 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 IPILIMUMAB.
MedlinePlus Drug Summary
Ipilimumab injection is used: to treat melanoma (a type of skin cancer) in adults and children 12 years of age and older that cannot be treated with surgery or that has spread to other parts of the body. It is also used in combination with nivolumab (Opdivo) to treat melanoma in adults that cannot be treated with surgery or that has spread to other parts of the body. to treat and prevent the return of a certain type of melanoma after surgery to remove it and any affected lymph nodes. in combination with nivolumab to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the cells of the kidneys). in combination with nivolumab to treat certain types 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 nivolumab to treat hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated with sorafenib (Nexafar). in combination with nivolumab to a certain type of lung cancer (non-small cell lung cancer; NSCLC) in adults that has spread to other parts of the body. in combination with nivolumab and platinum-containing chemotherapy to treat a certain type of NSCLC in adults that has returned or has spread to other parts of the body. in combination with nivolumab to treat 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. and in combination with nivolumab to treat a certain type of esophageal cancer (cancer of the tube that connects your throat to your stomach) that has spread to other parts of the body or cannot be treated with surgery. Ipilimumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
Related Packages: 00003-2328-22Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ipilimumab Injection
Product Information
| NDC | 00003-2328 |
|---|---|
| Product ID | 0003-2328_839bc9a8-9583-41fa-beb6-728ef542fa72 |
| Associated GPIs | 21355232002040 |
| GCN Sequence Number | 067200 |
| GCN Sequence Number Description | ipilimumab VIAL 200MG/40ML INTRAVEN |
| HIC3 | V3J |
| HIC3 Description | CYTOTOXIC T-LYMPHOCYTE ANTIGEN(CTLA-4)RMC ANTIBODY |
| GCN | 29689 |
| HICL Sequence Number | 037503 |
| HICL Sequence Number Description | IPILIMUMAB |
| Brand/Generic | Brand |
| Proprietary Name | YERVOY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ipilimumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | IPILIMUMAB |
| Labeler Name | E.R. Squibb & Sons, L.L.C. |
| Pharmaceutical Class | CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125377 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00003-2328-22 (00003232822)
| NDC Package Code | 0003-2328-22 |
|---|---|
| Billing NDC | 00003232822 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (0003-2328-22) / 40 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2011-03-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |