Nephroscan Injection, Powder, Lyophilized, For Solution
NDC Package 71083-0020-5

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

Package Information

Nephroscan (succimer) injection is a medication used to treat lead poisoning. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Theragnostics Inc, this product is identified by NDC 71083-0020 and is authorized under FDA application NDA214993.

Identification & Billing

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
11-Digit Billing Format
71083002005

Clinical Specifications

Proprietary Name
Nephroscan
Non-Proprietary Name
Succimer
Substance Name
Succimer
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SUCCIMER 1 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Theragnostics Inc
Product Type
Human Prescription Drug
FDA Application #
NDA214993
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-18-2022
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71083-0020-5 identifies a specific commercial 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. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains succimer 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 Theragnostics Inc on February 18, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Theragnostics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71083002005. 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 (5-4-1)
71083-0020-5
11-Digit CMS (5-4-2)
71083-0020-05

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