Evenity Injection, Solution
NDC Package 55513-998-02

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

Package Information

Evenity (romosozumab-aqqg) injection is romosozumab-aqqg is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). This formulation utilizes a injection, solution delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-998 and is authorized under FDA application BLA761062.

Identification & Billing

NDC Package Code
55513-998-02
Package Description
2 SYRINGE, GLASS in 1 CARTON / 1.17 mL in 1 SYRINGE, GLASS (55513-998-01)
Product Code
55513-998
11-Digit Billing Format
55513099802
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2123184 - romosozumab-aqqg 105 MG in 1.17 mL Prefilled Syringe
  • RxCUI: 2123184 - 1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe
  • RxCUI: 2123185 - {2 (1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe) } Pack
  • RxCUI: 2123185 - romosozumab-aqqg 89.7 MG/ML in 1.17 ML Prefilled Syringe 2-Pack (210 MG Dose)
  • RxCUI: 2123190 - Evenity 105 MG in 1.17 mL Prefilled Syringe

Clinical Specifications

Proprietary Name
Evenity
Non-Proprietary Name
Romosozumab-aqqg
Substance Name
Romosozumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ROMOSOZUMAB 105 mg/1.17mL
Usage Information
Romosozumab-aqqg is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture.

Regulatory & Marketing

Labeler Name
Amgen, Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761062
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2024
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.

J3111
Source: ASP
Inj. romosozumab-aqqg 1 mg
HCPCS Dosage 1 MG
Units / Pkg 210

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55513-998-02 identifies a specific commercial package of 2 syringe, glass in 1 carton / 1.17 ml in 1 syringe, glass (55513-998-01) of Evenity, a human prescription drug labeled by Amgen, Inc. This injection, solution is formulated for subcutaneous use and contains romosozumab 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 July 01, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Romosozumab-aqqg is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513099802. 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)
55513-998-02
11-Digit CMS (5-4-2)
55513-0998-02

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