NDC 0078-0923 Kisqali Femara Co-pack

Letrozole And Ribociclib Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0923
Proprietary Name:
Kisqali Femara Co-pack
Non-Proprietary Name: [1]
Letrozole And Ribociclib
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Novartis Pharmaceuticals Corporation
Labeler Code:
0078
FDA Application Number: [6]
NDA209935
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-04-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - DARK YELLOW)
PURPLE (C48327 - LIGHT GREYISH VIOLET)
Shape:
ROUND (C48348)
Size(s):
7 MM
14 MM
11 MM
Imprint(s):
FV;CG
RIC;NVR
Score:
1

Product Packages

NDC Code 0078-0923-61

Package Description: 1 KIT in 1 KIT * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0902-21)

Product Details

What is NDC 0078-0923?

The NDC code 0078-0923 is assigned by the FDA to the product Kisqali Femara Co-pack which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Kisqali Femara Co-pack is letrozole and ribociclib. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0078-0923-61 1 kit in 1 kit * 28 tablet, film coated in 1 bottle, plastic (0078-0881-50) * 21 tablet in 1 blister pack (0078-0902-21). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Kisqali Femara Co-pack?

This product contains 2 medications: ribociclib tablets and letrozole tablets. This product is used to treat breast cancer. Ribociclib works by slowing or stopping the growth of cancer cells. Letrozole works by decreasing the amount of estrogen the body makes, which helps slow down or reverse the growth of some breast cancers.

Which are Kisqali Femara Co-pack UNII Codes?

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

Which are Kisqali Femara Co-pack 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:

What is the NDC to RxNorm Crosswalk for Kisqali Femara Co-pack?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Letrozole


Letrozole is used treat early breast cancer in women who have experienced menopause (change of life; end of monthly menstrual periods) and who have had other treatments, such as radiation or surgery to remove the tumor. It is also used to treat early breast cancer in women who have experienced menopause and who have already been treated with a medication called tamoxifen (Nolvadex) for 5 years. Letrozole is also used in women who have experienced menopause as a first treatment of breast cancer that has spread within the breast or to other areas of the body or in women whose breast cancer has worsened while they were taking tamoxifen. Letrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.
[Learn More]


Ribociclib


Ribociclib is used in combination with another medication to treat a certain type of hormone receptor–positive (depends on hormones such as estrogen to grow) advanced breast cancer or that has spread to other parts of the body in women who have not experienced menopause (change of life; end of monthly menstrual periods) and in those who are close to or who have already experienced menopause. Ribociclib is also used in combination with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive advanced breast cancer or that has spread to other parts of the body as an initial treatment or in people who have not been treated successfully with other treatments in women who have already experienced menopause. Ribociclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
[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 disclaimer below.

Product Footnotes

[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.

[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.

[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".