Prolia Injection
NDC Package 55513-710-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Prolia (denosumab) injection is denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. This formulation utilizes a injection delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-710 and is authorized under FDA application BLA125320.

Identification & Billing

NDC Package Code
55513-710-01
Package Description
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
55513-710
11-Digit Billing Format
55513071001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prolia
Non-Proprietary Name
Denosumab
Substance Name
Denosumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
DENOSUMAB 60 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Amgen, Inc
Product Type
Human Prescription Drug
FDA Application #
BLA125320
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-05-2010
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0897
Source: PDAC
INJECTION, DENOSUMAB, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55513-710). Click a package code to view its specific billing and regulatory data.

55513-710-21
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

* 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 55513-710-01 identifies a specific commercial package of 1 syringe in 1 carton / 1 ml in 1 syringe of Prolia, a human prescription drug labeled by Amgen, Inc. This injection is formulated for subcutaneous use and contains denosumab 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 05, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Amgen, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513071001. 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)
55513-710-01
11-Digit CMS (5-4-2)
55513-0710-01

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