Sutent
NDC 63539-017

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63539-017?
  5. Sutent Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sutent is a NDA-approved product labeled by U.s. Pharmaceuticals. This medication is used to treat certain types of cancer (kidney, pancreas, and intestinal). It is supplied as a brown product. This product entry covers the primary NDC 63539-017 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63539-017
Proprietary Name:
Sutent
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
U.s. Pharmaceuticals
Labeler Code:
63539
Product Label ID:
a5d555f5-d66a-4f94-abcf-96fa6d71a32f
FDA Application Number: [6]
NDA021938
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-26-2006
End Marketing Date: [10]
10-31-2022
Listing Expiration Date: [11]
10-31-2022
Exclude Flag: [12]
D

Product Characteristics

Color(s):
BROWN (C48332 - CARAMEL)
ORANGE (C48331)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
14 MM
Imprint(s):
PFIZER;STN;50;MG
PFIZER;STN;12;5;MG
Score:
1

Code Structure Chart

Product Details

What is NDC 63539-017?

The NDC code 63539-017 is assigned by the FDA to the product Sutent. This pharmaceutical product is labeled by U.s. Pharmaceuticals and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63539-017-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat certain types of cancer (kidney, pancreas, and intestinal). It is also used to treat people who are at high risk of the kidney cancer coming back again after having kidney surgery. Sunitinib works by stopping or slowing the growth of cancer tumors. It also works by slowing the growth of new blood vessels within the tumor.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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:

* Please review the full disclaimer at the bottom of this page.

Patient Education

Sunitinib


Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus (tube that connects the throat with the stomach) in people with tumors that were not treated successfully with imatinib (Gleevec) or people who cannot take imatinib. Sunitinib is also used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys). Sunitinib is also used to help prevent the return of RCC in people who have RCC that has not spread and have had a kidney removed. Sunitinib is also used to treat pancreatic neuroendocrine tumors (pNET, a type of tumor that begins in certain cells of the pancreas) in people with tumors that have worsened and cannot be treated with surgery. Sunitinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
[Learn More]


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:

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


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".