Epoetin Alfa Solution
NDC Package 55513-101-80

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Epoetin Alfa solution 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). This formulation utilizes a solution delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-101.

Identification & Billing

NDC Package Code
55513-101-80
Package Description
621 VIAL in 1 TRAY / 1 mL in 1 VIAL
Product Code
55513-101
11-Digit Billing Format
55513010180

Clinical Specifications

Proprietary Name
Epoetin Alfa
Non-Proprietary Name
Epoetin Alfa
Substance Name
Epoetin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
EPOETIN 2000 [iU]/mL
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
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-01-1989
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 55513-101-80 identifies a specific commercial package of 621 vial in 1 tray / 1 ml in 1 vial of Epoetin Alfa (UNFINISHED drug), drug for further processing labeled by Amgen, Inc. This solution is formulated for use and contains epoetin 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 Amgen, Inc on June 01, 1989. 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 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: 55513010180. 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)
55513-101-80
11-Digit CMS (5-4-2)
55513-0101-80

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