Kisqali Femara Co-pack Kit
NDC Package 0078-0909-61

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Kisqali Femara Co-pack (letrozole and ribociclib) kits is this product contains 2 medications: ribociclib tablets and letrozole tablets. This formulation utilizes a kit delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0909 and is authorized under FDA application NDA209935.

Identification & Billing

NDC Package Code
0078-0909-61
Package Description
1 KIT in 1 KIT * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0888-21)
Product Code
0078-0909
11-Digit Billing Format
00078090961
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kisqali Femara Co-pack
Non-Proprietary Name
Letrozole And Ribociclib
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA209935
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-04-2017
End Marketing Date
08-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0909-61 identifies a specific commercial package of 1 kit in 1 kit * 28 tablet, film coated in 1 bottle, plastic (0078-0881-50) * 21 tablet in 1 blister pack (0078-0888-21) of Kisqali Femara Co-pack, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on May 04, 2017.

What are the primary indications for this medication?

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.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078090961. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-0909-61
11-Digit CMS (5-4-2)
00078-0909-61

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.