Epogen
NDC Package 55513-823-10

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.

Epogen is a medication used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). Marketed by Amgen Inc, this product is identified by NDC 55513-823 and is authorized under FDA application BLA103234.

Identification & Billing

NDC Package Code
55513-823-10
Package Description
10 VIAL in 1 PACKAGE / 1 mL in 1 VIAL (55513-823-01)
Product Code
55513-823
11-Digit Billing Format
55513082310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Epogen
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 failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). It may also be used in anemic patients to reduce the need for blood transfusions before certain planned surgeries that have a high risk of blood loss (usually given with an anticoagulant/"blood thinner" medication such as warfarin to lower the risk of serious blood clots). Epoetin alfa works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.

Regulatory & Marketing

Labeler Name
Amgen Inc
FDA Application #
BLA103234
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-03-1997
End Marketing Date
10-19-2017
Listing Expiration
10-19-2017
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 55513-823-10 identifies a specific commercial package of 10 vial in 1 package / 1 ml in 1 vial (55513-823-01) of Epogen, labeled by Amgen 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 Amgen Inc on March 03, 1997. The current certification is valid through October 19, 2017.

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 failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). It may also be used in anemic patients to reduce the need for blood transfusions before certain planned surgeries that have a high risk of blood loss (usually given with an anticoagulant/"blood thinner" medication such as warfarin to lower the risk of serious blood clots). Epoetin alfa works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.

How is this Amgen Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513082310. 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)
55513-823-10
11-Digit CMS (5-4-2)
55513-0823-10

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