NDC 0310-4500 Imfinzi
Durvalumab Injection, Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 0310-4500?
What are the uses for Imfinzi?
What are Imfinzi Active Ingredients?
Which are Imfinzi UNII Codes?
The UNII codes for the active ingredients in this product are:
- DURVALUMAB (UNII: 28X28X9OKV)
- DURVALUMAB (UNII: 28X28X9OKV) (Active Moiety)
Which are Imfinzi Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- HISTIDINE (UNII: 4QD397987E)
- HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (UNII: X573657P6P)
- TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for Imfinzi?
- RxCUI: 1919507 - durvalumab 120 in 2.4 ML Injection
- RxCUI: 1919507 - 2.4 ML durvalumab 50 MG/ML Injection
- RxCUI: 1919507 - durvalumab 120 per 2.4 ML Injection
- RxCUI: 1919512 - IMFINZI 120 MG in 2.4 ML Injection
- RxCUI: 1919512 - 2.4 ML durvalumab 50 MG/ML Injection [Imfinzi]
Which are the Pharmacologic Classes for Imfinzi?
* Please review the disclaimer below.
Patient Education
Durvalumab Injection
Durvalumab is used alone 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. It is also used in combination with tremelimumab-actl (Imjudo) and platinum-based chemotherapy to treat a certain type of NSCLC that has spread throughout the lungs and to other parts of the body. 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 is also used in combination with tremelimumab-actl to treat hepatocellular carcinoma (HCC; a type of liver cancer) that cannot be treated with surgery. 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.
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Cancer Chemotherapy
What is cancer chemotherapy?
Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.
Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.
Chemotherapy is used to:
- Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
- Ease cancer symptoms by shrinking tumors that are causing pain and other problems.
What are the side effects of chemotherapy?
Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.
You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.
Some common side effects are:
- Mouth sores
- Fatigue
- Nausea and vomiting
- Pain
- Hair loss
There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.
What can I expect when getting chemotherapy?
You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).
Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.
Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.
NIH: National Cancer Institute
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".