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  5. NDC Package Code: 71083-0020-5 Nephroscan

NDC Package 71083-0020-5 Nephroscan

Succimer Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
71083-0020-5
Package Description:
5 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)
Product Code:
71083-0020
Proprietary Name:
Nephroscan
Non-Proprietary Name:
Succimer
Substance Name:
Succimer
Usage Information:
This medication is used to treat lead poisoning. It works by binding to the lead so that it may be removed by your kidneys. Removing lead from your body will lower the chance of severe problems caused by lead poisoning.
11-Digit NDC Billing Format:
71083002005
Product Type:
Human Prescription Drug
Labeler Name:
Theragnostics Inc
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SUCCIMER 1 mg/1
    • Pharmacologic Class(es):
  • Lead Chelating Activity - [MoA] (Mechanism of Action)
  • Lead Chelator - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA214993
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-18-2022
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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 71083-0020-5?

    The NDC Packaged Code 71083-0020-5 is assigned to a package of 5 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose (71083-0020-1) of Nephroscan, a human prescription drug labeled by Theragnostics Inc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 71083-0020 included in the NDC Directory?

    Yes, Nephroscan with product code 71083-0020 is active and included in the NDC Directory. The product was first marketed by Theragnostics Inc on February 18, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71083-0020-5?

    The 11-digit format is 71083002005. 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 5-4-1 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
    5-4-171083-0020-55-4-271083-0020-05