Parsabiv Injection, Solution
NDC Package 55513-741-10

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

Parsabiv (etelcalcetide) injection is a medication used to treat increased amounts of a certain hormone (parathyroid) in people with long-term kidney disease who are on dialysis. This formulation utilizes a injection, solution delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-741 and is authorized under FDA application NDA208325.

Identification & Billing

NDC Package Code
55513-741-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)
Product Code
55513-741
11-Digit Billing Format
55513074110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Parsabiv
Non-Proprietary Name
Etelcalcetide
Substance Name
Etelcalcetide Hydrochloride
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ETELCALCETIDE HYDROCHLORIDE 5 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat increased amounts of a certain hormone (parathyroid) in people with long-term kidney disease who are on dialysis. Dialysis treatment usually causes higher than normal amounts of certain substances (such as parathyroid hormone, calcium, phosphorus) in your body. This medication works by decreasing how much parathyroid hormone your body makes. This effect helps lower calcium and phosphorus levels in your blood. Having the right amounts of parathyroid hormone, calcium, and phosphorus in your body can help prevent bone problems.

Regulatory & Marketing

Labeler Name
Amgen, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA208325
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-03-2017
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.

J0606
Source: OPPS
Inj, etelcalcetide, 0.1 mg
HCPCS Dosage 0.1 MG
Units / Pkg 500

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 (55513-741). Click a package code to view its specific billing and regulatory data.

55513-741-20
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01)

* 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 55513-741-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose (55513-741-01) of Parsabiv, a human prescription drug labeled by Amgen, Inc. This injection, solution is formulated for intravenous use and contains etelcalcetide hydrochloride 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 April 03, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat increased amounts of a certain hormone (parathyroid) in people with long-term kidney disease who are on dialysis. Dialysis treatment usually causes higher than normal amounts of certain substances (such as parathyroid hormone, calcium, phosphorus) in your body. This medication works by decreasing how much parathyroid hormone your body makes. This effect helps lower calcium and phosphorus levels in your blood. Having the right amounts of parathyroid hormone, calcium, and phosphorus in your body can help prevent bone problems.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513074110. 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)
55513-741-10
11-Digit CMS (5-4-2)
55513-0741-10

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