NDC Package 55513-710-01 Prolia

Denosumab Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
55513-710-01
Package Description:
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code:
Proprietary Name:
Prolia
Non-Proprietary Name:
Denosumab
Substance Name:
Denosumab
Usage Information:
Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone.
11-Digit NDC Billing Format:
55513071001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 993452 - denosumab 60 MG in 1 ML Prefilled Syringe
  • RxCUI: 993452 - 1 ML denosumab 60 MG/ML Prefilled Syringe
  • RxCUI: 993452 - denosumab 60 MG per 1 ML Prefilled Syringe
  • RxCUI: 993456 - Prolia 60 MG in 1 ML Prefilled Syringe
  • RxCUI: 993456 - 1 ML denosumab 60 MG/ML Prefilled Syringe [Prolia]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amgen Inc
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125320
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-05-2010
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 55513-710-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    55513071001J0897Denosumab injection1 MG116060

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    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    55513-710-211 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

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    Frequently Asked Questions

    What is NDC 55513-710-01?

    The NDC Packaged Code 55513-710-01 is assigned to a package of 1 syringe in 1 carton / 1 ml in 1 syringe of Prolia, a human prescription drug labeled by Amgen Inc. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 55513-710 included in the NDC Directory?

    Yes, Prolia with product code 55513-710 is active and included in the NDC Directory. The product was first marketed by Amgen Inc on June 05, 2010 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 55513-710-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 55513-710-01?

    The 11-digit format is 55513071001. 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
    5-3-255513-710-015-4-255513-0710-01