Mircera Injection, Solution
NDC Package 59353-404-09

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

Package Information

Mircera (methoxy polyethylene glycol-epoetin beta) injection is a medication used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney disease). This formulation utilizes a injection, solution delivery system. Marketed by Vifor (international) Inc., this product is identified by NDC 59353-404 and is authorized under FDA application BLA125164.

Identification & Billing

NDC Package Code
59353-404-09
Package Description
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code
59353-404
11-Digit Billing Format
59353040409
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mircera
Non-Proprietary Name
Methoxy Polyethylene Glycol-epoetin Beta
Substance Name
Methoxy Polyethylene Glycol-epoetin Beta
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 150 ug/.3mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Vifor (international) Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125164
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-24-2014
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 59353-404-09 identifies a specific commercial 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.. This injection, solution is formulated for intravenous use and contains methoxy polyethylene glycol-epoetin beta 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 Vifor (international) Inc. on October 24, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Vifor (international) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59353040409. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
59353-404-09
11-Digit CMS (5-4-2)
59353-0404-09

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