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  5. NDC Package Code: 55513-101-80 Epoetin Alfa

NDC Package 55513-101-80 Epoetin Alfa

Solution - View Billable Units, 11-Digit Format, RxNorm

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.

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:
55513-101-80
Package Description:
621 VIAL in 1 TRAY / 1 mL in 1 VIAL
Product Code:
55513-101
Non-Proprietary Name:
Epoetin Alfa
Substance Name:
Epoetin
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.
11-Digit NDC Billing Format:
55513010180
Product Type:
Drug For Further Processing
Labeler Name:
Amgen Inc
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
    • Sample Package:
    N/A
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 55513-101-80?

    The NDC Packaged Code 55513-101-80 is assigned to an UNFINISHED drug package of 621 vial in 1 tray / 1 ml in 1 vial of Epoetin Alfa, drug for further processing labeled by Amgen Inc. The product's dosage form is solution and is administered via form.

    Is NDC 55513-101 included in the NDC Directory?

    Yes, Epoetin Alfa is an UNFINISHED PRODUCT with code 55513-101 that is active and included in the NDC Directory. The product was first marketed by Amgen Inc on June 01, 1989 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 11-digit format for NDC 55513-101-80?

    The 11-digit format is 55513010180. 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
    5-3-255513-101-805-4-255513-0101-80