NDC Package 59353-400-09 Mircera

Methoxy Polyethylene Glycol-epoetin Beta Injection, 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:
59353-400-09
Package Description:
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code:
Proprietary Name:
Mircera
Non-Proprietary Name:
Methoxy Polyethylene Glycol-epoetin Beta
Substance Name:
Methoxy Polyethylene Glycol-epoetin Beta
Usage Information:
This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney disease). It works by signaling the bone marrow to make more red blood cells. Methoxy polyethylene glycol-epoetin beta helps to reverse anemia. It also helps to reduce the need for blood transfusions. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.
11-Digit NDC Billing Format:
59353040009
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1591961 - MIRCERA 50 MCG in 0.3 ML Prefilled Syringe
  • RxCUI: 1591961 - 0.3 ML methoxy polyethylene glycol-epoetin beta 0.167 MG/ML Prefilled Syringe [Mircera]
  • RxCUI: 1591961 - Mircera 0.05 MG per 0.3 ML Prefilled Syringe
  • RxCUI: 1591961 - Mircera 50 MCG per 0.3 ML Prefilled Syringe
  • RxCUI: 1591964 - MIRCERA 75 MCG in 0.3 ML Prefilled Syringe
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Vifor (international) Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    BLA125164
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-24-2014
    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 59353-400-09?

    The NDC Packaged Code 59353-400-09 is assigned to a package of 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Mircera, a human prescription drug labeled by Vifor (international) Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 59353-400 included in the NDC Directory?

    Yes, Mircera with product code 59353-400 is active and included in the NDC Directory. The product was first marketed by Vifor (international) Inc. on October 24, 2014 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 NDC billing unit for package 59353-400-09?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 59353-400-09?

    The 11-digit format is 59353040009. 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
    5-3-259353-400-095-4-259353-0400-09