Etelcalcetide Hydrochloride Solution
NDC Package 63552-030-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Etelcalcetide Hydrochloride solution 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 solution delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-030.

Identification & Billing

NDC Package Code
63552-030-00
Package Description
621 VIAL in 1 TRAY / 3 mL in 1 VIAL
Product Code
63552-030
11-Digit Billing Format
63552003000

Clinical Specifications

Proprietary Name
Etelcalcetide Hydrochloride
Non-Proprietary Name
Etelcalcetide Hydrochloride
Substance Name
Etelcalcetide Hydrochloride
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)
ETELCALCETIDE HYDROCHLORIDE 5 mg/mL
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
Patheon Manufacturing Services Llc
Product Type
Drug For Further Processing
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
04-03-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63552-030-00 identifies a specific commercial package of 621 vial in 1 tray / 3 ml in 1 vial of Etelcalcetide Hydrochloride (UNFINISHED drug), drug for further processing labeled by Patheon Manufacturing Services Llc. This solution is formulated for 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 Patheon Manufacturing Services Llc on April 03, 2017. The current certification is valid through December 31, 2026.

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 Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552003000. 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)
63552-030-00
11-Digit CMS (5-4-2)
63552-0030-00

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