Thyroshield
NDC Package 59465-210-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Thyroshield is •use as directed by public officials in the event of a nuclear radiation emergency.•do not take more than 1 dose in 24 hours.Dosing Chart(dropper inside)Adults over 18 years 2 mL every day (130 mg) andChildren over 12 years to 18 yearswho weigh at least 150 pounds2 mL every day (130 mg)Children over 12 years to 18 yearswho weigh less than 150 pounds1 mL every day (65 mg)andChildren over 3 years to 12 years1 mL every day (65 mg)Children over 1 month to 3 years0.5 mL every day (32.5 mg)Babies at birth to 1 month0.25 mL every day (16.25 mg)If pregnant, breastfeeding, have a baby up to 1 month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact a doctor as soon as possible. Marketed by Arco Pharmaceuticals Llc, this product is identified by NDC 59465-210 and is authorized under FDA application ANDA077218.

Identification & Billing

NDC Package Code
59465-210-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER
Product Code
59465-210
11-Digit Billing Format
59465021001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thyroshield
Dosage Form
-
Usage Information
•use as directed by public officials in the event of a nuclear radiation emergency.•do not take more than 1 dose in 24 hours.Dosing Chart(dropper inside)Adults over 18 years 2 mL every day (130 mg) andChildren over 12 years to 18 yearswho weigh at least 150 pounds2 mL every day (130 mg)Children over 12 years to 18 yearswho weigh less than 150 pounds1 mL every day (65 mg)andChildren over 3 years to 12 years1 mL every day (65 mg)Children over 1 month to 3 years0.5 mL every day (32.5 mg)Babies at birth to 1 month0.25 mL every day (16.25 mg)If pregnant, breastfeeding, have a baby up to 1 month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact a doctor as soon as possible.

Regulatory & Marketing

Labeler Name
Arco Pharmaceuticals Llc
FDA Application #
ANDA077218
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2014
Listing Expiration
12-31-2017
Exclude Flag
I
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 59465-210-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 30 ml in 1 bottle, dropper of Thyroshield, labeled by Arco Pharmaceuticals Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Arco Pharmaceuticals Llc on September 01, 2014. The current certification is valid through December 31, 2017.

How is this Arco Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59465021001. 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)
59465-210-01
11-Digit CMS (5-4-2)
59465-0210-01

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