Decitabine Injection, Powder, Lyophilized, For Solution
NDC Package 68083-528-01

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

Package Information

Decitabine injection 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 injection, powder, lyophilized, for solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-528 and is authorized under FDA application ANDA205539.

Identification & Billing

NDC Package Code
68083-528-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
68083-528
11-Digit Billing Format
68083052801
RxNorm Crosswalk
RxCUI: 636631 - decitabine 50 MG Injection

Clinical Specifications

Proprietary Name
Decitabine
Non-Proprietary Name
Decitabine
Substance Name
Decitabine
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DECITABINE 50 mg/10mL
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 may have problems such as infections, anemia, and easy bleeding/bruising. Decitabine is a chemotherapy drug. It is believed to work by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions. Decitabine also kills abnormal blood cells that have grown too fast and do not work properly.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205539
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2020
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 68083-528-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Decitabine, a human prescription drug labeled by Gland Pharma Limited. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains decitabine 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 Gland Pharma Limited on November 23, 2020. The current certification is valid through December 31, 2026.

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 may have problems such as infections, anemia, and easy bleeding/bruising. Decitabine is a chemotherapy drug. It is believed to work by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions. Decitabine also kills abnormal blood cells that have grown too fast and do not work properly.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083052801. 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)
68083-528-01
11-Digit CMS (5-4-2)
68083-0528-01

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