Azacitidine
NDC Package 69097-368-40

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

Package Information

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

Azacitidine 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. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-368 and is authorized under FDA application ANDA209540.

Identification & Billing

NDC Package Code
69097-368-40
Package Description
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON
Product Code
69097-368
11-Digit Billing Format
69097036840

Clinical Specifications

Proprietary Name
Azacitidine
Dosage Form
-
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
Cipla Usa Inc.
FDA Application #
ANDA209540
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-04-2018
End Marketing Date
12-15-2023
Listing Expiration
12-15-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69097-368-40 identifies a specific commercial package of 1 injection, powder, lyophilized, for solution in 1 carton of Azacitidine, labeled by Cipla Usa Inc.. 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 Cipla Usa Inc. on May 04, 2018. The current certification is valid through December 15, 2023.

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 Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097036840. 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)
69097-368-40
11-Digit CMS (5-4-2)
69097-0368-40

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