Anastrozole Tablet, Coated
NDC Package 72789-342-15

11-digit billing NDC: 72789034215
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Anastrozole tablets is hypersensitivityAnastrozole tablets are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. This formulation utilizes a tablet, coated delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-342 and is authorized under FDA application ANDA078921.

Identification & Billing

NDC Package Code
72789-342-15
Package Description
15 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
72789-342
11-Digit Billing Format
72789034215
RxNorm Crosswalk
RxCUI: 199224 - anastrozole 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Anastrozole
Non-Proprietary Name
Anastrozole
Substance Name
Anastrozole
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ANASTROZOLE 1 mg/1
Pharmacologic Class
Usage Information
HypersensitivityAnastrozole tablets are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions ( 6.2)] .

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2010
Listing Expiration
12-31-2027
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 72789-342-15 identifies a specific commercial package of 15 tablet, coated in 1 bottle, plastic of Anastrozole, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This tablet, coated is formulated for oral use and contains anastrozole 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 Pd-rx Pharmaceuticals, Inc. on June 27, 2010. The current certification is valid through December 31, 2027.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789034215. 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)
72789-342-15
11-Digit CMS (5-4-2)
72789-0342-15

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