The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System Kit
NDC Package 84828-569-00

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

Package Information

The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System (minoxidil) kits is minoxidil is used with other medications to treat high blood pressure (hypertension). This formulation utilizes a kit delivery system. Marketed by Invest Strong, Llc, this product is identified by NDC 84828-569 and is authorized under FDA application ANDA078176.

Identification & Billing

NDC Package Code
84828-569-00
Package Description
1 KIT in 1 KIT * 1 BOTTLE, DROPPER in 1 KIT (84828-539-00) / 60 mL in 1 BOTTLE, DROPPER
Product Code
84828-569
11-Digit Billing Format
84828056900
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System
Non-Proprietary Name
Minoxidil
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Minoxidil is used with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Minoxidil works by relaxing blood vessels so blood can flow more easily.

Regulatory & Marketing

Labeler Name
Invest Strong, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA078176
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-11-2024
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 84828-569-00 identifies a specific commercial package of 1 kit in 1 kit * 1 bottle, dropper in 1 kit (84828-539-00) / 60 ml in 1 bottle, dropper of The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System, a human over the counter drug labeled by Invest Strong, Llc. This kit is formulated for use and contains 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 Invest Strong, Llc on September 11, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Minoxidil is used with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Minoxidil works by relaxing blood vessels so blood can flow more easily.

How is this Invest Strong, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84828056900. 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)
84828-569-00
11-Digit CMS (5-4-2)
84828-0569-00

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