Minoxidil Aerosol, Foam
NDC Package 80855-201-06

11-digit billing NDC: 80855020106
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Minoxidil aerosols is see enclosed leaflet for complete directions on how to useapply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands wellusing more or more often will not improve resultscontinued use is necessary to increase and keep your hair regrowth, or hair loss will begin again. This formulation utilizes a aerosol, foam delivery system. Marketed by Virtue Labs, Llc, this product is identified by NDC 80855-201 and is authorized under FDA application ANDA209074.

Identification & Billing

NDC Package Code
80855-201-06
Package Description
2 CAN in 1 PACKAGE / 60 g in 1 CAN
Product Code
80855-201
11-Digit Billing Format
80855020106
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Minoxidil (for Women)
Non-Proprietary Name
Minoxidil
Substance Name
Minoxidil
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
MINOXIDIL 50 mg/g
Pharmacologic Class
Usage Information
See enclosed leaflet for complete directions on how to useapply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands wellusing more or more often will not improve resultscontinued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Regulatory & Marketing

Labeler Name
Virtue Labs, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA209074
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-23-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80855-201). Click a package code to view its specific billing and regulatory data.

80855-201-05
1 CAN in 1 PACKAGE / 60 g in 1 CAN

* 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 80855-201-06 identifies a specific commercial package of 2 can in 1 package / 60 g in 1 can of Minoxidil (for Women), a human over the counter drug labeled by Virtue Labs, Llc. This aerosol, foam is formulated for topical use and contains minoxidil 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 Virtue Labs, Llc on December 23, 2020. The current certification is valid through December 31, 2027.

How is this Virtue Labs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80855020106. 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)
80855-201-06
11-Digit CMS (5-4-2)
80855-0201-06

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