Profolix Minoxidil Hair Growth Serum
NDC Package 81653-009-01

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

Package Information

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

Profolix Minoxidil Hair Growth Serum is roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions. Marketed by Guangzhou Jianyuan Biological Technology.co.,ltd, this product is identified by NDC 81653-009 and is authorized under FDA application ANDA075357.

Identification & Billing

NDC Package Code
81653-009-01
Package Description
60 mL in 1 BOTTLE
Product Code
81653-009
11-Digit Billing Format
81653000901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Profolix Minoxidil Hair Growth Serum
Dosage Form
-
Usage Information
Roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions. Apply 2-3 drops to the treated scalp area. Massage in with fingers and wash hands thoroughly. More serum or frequent use won't enhance results. Consistent use is key for hair regrowth. Stopping may lead to hair loss. Results may take at least 4 months with daily use (recommended: men: Once daily, Women: Twice daily) Effectiveness varies from person to person.

Regulatory & Marketing

Labeler Name
Guangzhou Jianyuan Biological Technology.co.,ltd
FDA Application #
ANDA075357
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-12-2023
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81653-009). Click a package code to view its specific billing and regulatory data.

81653-009-02
180 mL in 1 BOTTLE

* 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 81653-009-01 identifies a specific commercial package of 60 ml in 1 bottle of Profolix Minoxidil Hair Growth Serum, labeled by Guangzhou Jianyuan Biological Technology.co.,ltd. 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 Guangzhou Jianyuan Biological Technology.co.,ltd on November 12, 2023. The current certification is valid through December 31, 2024.

How is this Guangzhou Jianyuan Biological Technology.co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81653000901. 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)
81653-009-01
11-Digit CMS (5-4-2)
81653-0009-01

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