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  5. NDC Package Code: 63552-029-00 Etelcalcetide Hydrochloride

NDC Package 63552-029-00 Etelcalcetide Hydrochloride

Solution - View Billable Units, 11-Digit Format, RxNorm

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.

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:
63552-029-00
Package Description:
621 VIAL in 1 TRAY / 3 mL in 1 VIAL
Product Code:
63552-029
Non-Proprietary Name:
Etelcalcetide Hydrochloride
Substance Name:
Etelcalcetide Hydrochloride
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.
11-Digit NDC Billing Format:
63552002900
Product Type:
Drug For Further Processing
Labeler Name:
Patheon Manufacturing Services Llc
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 2.5 mg/.5mL
    • Sample Package:
    N/A
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 63552-029-00?

    The NDC Packaged Code 63552-029-00 is assigned to an UNFINISHED drug package of 621 vial in 1 tray / 3 ml in 1 vial of Etelcalcetide Hydrochloride, drug for further processing labeled by Patheon Manufacturing Services Llc. The product's dosage form is solution and is administered via form.

    Is NDC 63552-029 included in the NDC Directory?

    Yes, Etelcalcetide Hydrochloride is an UNFINISHED PRODUCT with code 63552-029 that is active and included in the NDC Directory. The product was first marketed by Patheon Manufacturing Services Llc on April 03, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63552-029-00?

    The 11-digit format is 63552002900. 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
    5-3-263552-029-005-4-263552-0029-00