Mircera
NDC Package 0004-0403-09

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.

Mircera is a medication used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney disease). Marketed by Genentech, Inc., this product is identified by NDC 0004-0403 and is authorized under FDA application BLA125164.

Identification & Billing

NDC Package Code
0004-0403-09
Package Description
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code
0004-0403
11-Digit Billing Format
00004040309
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Mircera
Dosage Form
-
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
Genentech, Inc.
FDA Application #
BLA125164
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-24-2014
End Marketing Date
07-31-2019
Listing Expiration
07-31-2019
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 0004-0403-09 identifies a specific commercial package of 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Mircera, labeled by Genentech, 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 Genentech, Inc. on October 24, 2014. The current certification is valid through July 31, 2019.

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 Genentech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00004040309. 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 (4-4-2)
0004-0403-09
11-Digit CMS (5-4-2)
00004-0403-09

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