NDC Package 69539-115-01 Decitabine

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69539-115-01
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE
Product Code:
Proprietary Name:
Decitabine
Non-Proprietary Name:
Decitabine
Substance Name:
Decitabine
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.
11-Digit NDC Billing Format:
69539011501
NDC to RxNorm Crosswalk:
  • RxCUI: 636631 - decitabine 50 MG Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Msn Laboratories Private Limited
    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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA212265
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-28-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 69539-115-01?

    The NDC Packaged Code 69539-115-01 is assigned to a package of 1 vial, single-use in 1 carton / 20 ml in 1 vial, single-use of Decitabine, a human prescription drug labeled by Msn Laboratories Private Limited. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 69539-115 included in the NDC Directory?

    Yes, Decitabine with product code 69539-115 is active and included in the NDC Directory. The product was first marketed by Msn Laboratories Private Limited on August 28, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69539-115-01?

    The 11-digit format is 69539011501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269539-115-015-4-269539-0115-01