Onureg Tablet, Film Coated
NDC Package 59572-730-07

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

Onureg (azacitidine) tablets is a medication used to treat a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS) in which the bone marrow does not produce enough healthy blood cells. This formulation utilizes a tablet, film coated delivery system. Marketed by Celgene Corporation, this product is identified by NDC 59572-730 and is authorized under FDA application NDA214120.

Identification & Billing

NDC Package Code
59572-730-07
Package Description
7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
59572-730
11-Digit Billing Format
59572073007
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Onureg
Non-Proprietary Name
Azacitidine
Substance Name
Azacitidine
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)
AZACITIDINE 200 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS) in which the bone marrow does not produce enough healthy blood cells. People with MDS usually have problems such as infections, anemia, and easy bleeding/bruising. Azacitidine is believed to work by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions. Azacitidine also kills abnormal blood cells that have grown too fast and do not work properly.

Regulatory & Marketing

Labeler Name
Celgene Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA214120
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59572-730). Click a package code to view its specific billing and regulatory data.

59572-730-14
14 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 59572-730-07 identifies a specific commercial package of 7 tablet, film coated in 1 blister pack of Onureg, a human prescription drug labeled by Celgene Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 7 billable units per package. This tablet, film coated is formulated for oral use and contains azacitidine 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 Celgene Corporation on September 01, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS) in which the bone marrow does not produce enough healthy blood cells. People with MDS usually have problems such as infections, anemia, and easy bleeding/bruising. Azacitidine is believed to work by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions. Azacitidine also kills abnormal blood cells that have grown too fast and do not work properly.

How is this Celgene Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59572073007. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 total billable units per package. 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)
59572-730-07
11-Digit CMS (5-4-2)
59572-0730-07

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