Letrozole
NDC Package 62756-511-08

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

Package Information

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

Letrozole is a medication used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. Marketed by Sun Pharmaceutical Industries Limited, this product is identified by NDC 62756-511 and is authorized under FDA application ANDA091466.

Identification & Billing

NDC Package Code
62756-511-08
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
62756-511
11-Digit Billing Format
62756051108

Clinical Specifications

Proprietary Name
Letrozole
Dosage Form
-
Usage Information
This medication is used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. Letrozole is also used to help prevent the cancer from returning. Some breast cancers are made to grow faster by a natural hormone called estrogen. Letrozole decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries Limited
FDA Application #
ANDA091466
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-2015
End Marketing Date
03-31-2019
Listing Expiration
03-31-2019
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62756-511). Click a package code to view its specific billing and regulatory data.

62756-511-18
1000 TABLET, FILM COATED in 1 BOTTLE
62756-511-83
30 TABLET, FILM COATED in 1 BOTTLE
62756-511-88
100 TABLET, FILM COATED in 1 BOTTLE

* 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 62756-511-08 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Letrozole, labeled by Sun Pharmaceutical Industries Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sun Pharmaceutical Industries Limited on September 09, 2015. The current certification is valid through March 31, 2019.

What are the primary indications for this medication?

This medication is used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. Letrozole is also used to help prevent the cancer from returning. Some breast cancers are made to grow faster by a natural hormone called estrogen. Letrozole decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers.

How is this Sun Pharmaceutical Industries Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62756051108. 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 (5-3-2)
62756-511-08
11-Digit CMS (5-4-2)
62756-0511-08

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