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NDC 00310-4611-50 IMFINZI 500 mg/10mL Details
IMFINZI 500 mg/10mL
IMFINZI is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is DURVALUMAB.
MedlinePlus Drug Summary
Durvalumab is used to treat non-small cell lung cancer (NSCLC) that spread to nearby tissues and cannot be removed by surgery but has not worsened after being treated with other chemotherapy medications and radiation treatments. Durvalumab injection is also used in combination with chemotherapy agents to treat extensive-stage small cell lung cancer (ES-SCLC) in adults whose cancer has spread throughout the lungs and to other parts of the body. It is also used in combination with chemotherapy agents to treat biliary tract cancer (BTC; cancer in the organs and ducts that make and store bile, the liquid made by the liver) in adults whose cancer has spread to nearby tissues or to other parts of the body. Durvalumab injection 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: 00310-4611-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Durvalumab Injection
Product Information
| NDC | 00310-4611 |
|---|---|
| Product ID | 0310-4611_50f25f3d-31a5-40a5-a970-36b3429457b8 |
| Associated GPIs | 21358229002030 |
| GCN Sequence Number | 077350 |
| GCN Sequence Number Description | durvalumab VIAL 500MG/10ML INTRAVEN |
| HIC3 | V3Y |
| HIC3 Description | ANTI-PROGRAMMED CELL DEATH-LIGAND 1 (PD-L1) MAB |
| GCN | 43333 |
| HICL Sequence Number | 044230 |
| HICL Sequence Number Description | DURVALUMAB |
| Brand/Generic | Brand |
| Proprietary Name | IMFINZI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Durvalumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/10mL |
| Substance Name | DURVALUMAB |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761069 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-4611-50 (00310461150)
| NDC Package Code | 0310-4611-50 |
|---|---|
| Billing NDC | 00310461150 |
| Package | 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL |
| Marketing Start Date | 2017-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |