Azathioprine Tablet
NDC Package 72789-129-30

11-digit billing NDC: 72789012930
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. This formulation utilizes a tablet delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-129 and is authorized under FDA application ANDA074069.

Identification & Billing

NDC Package Code
72789-129-30
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
72789-129
11-Digit Billing Format
72789012930
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azathioprine
Non-Proprietary Name
Azathioprine
Substance Name
Azathioprine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AZATHIOPRINE 50 mg/1
Pharmacologic Class
Usage Information
Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.Renal Homotransplantation:Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis:Azathioprine tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of azathioprine tablets with these agents cannot be recommended.

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA074069
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-02-2015
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 72789-129-30 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Azathioprine, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains azathioprine 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 February 02, 2015. 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: 72789012930. 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)
72789-129-30
11-Digit CMS (5-4-2)
72789-0129-30

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