Letrozole Tablet, Film Coated
NDC Package 17856-0032-1

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

Package Information

Letrozole tablets is a medication used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. This formulation utilizes a tablet, film coated delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0032 and is authorized under FDA application ANDA090934.

Identification & Billing

NDC Package Code
17856-0032-1
Package Description
100 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 POUCH
Product Code
17856-0032
11-Digit Billing Format
17856003201
RxNorm Crosswalk
RxCUI: 200064 - letrozole 2.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Letrozole
Non-Proprietary Name
Letrozole
Substance Name
Letrozole
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LETROZOLE 2.5 mg/1
Pharmacologic Class
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
Atlantic Biologicals Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA090934
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-13-2020
Listing Expiration
12-31-2026
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 17856-0032-1 identifies a specific commercial package of 100 pouch in 1 box, unit-dose / 1 tablet, film coated in 1 pouch of Letrozole, a human prescription drug labeled by Atlantic Biologicals Corp.. This tablet, film coated is formulated for oral use and contains letrozole 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 Atlantic Biologicals Corp. on January 13, 2020. The current certification is valid through December 31, 2026.

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 Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856003201. 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 (5-4-1)
17856-0032-1
11-Digit CMS (5-4-2)
17856-0032-01

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