Elevate Hair Regrowth Treatment 5 Minoxidil Solution
NDC Package 84561-514-00

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

Package Information

Elevate Hair Regrowth Treatment 5 Minoxidil Solution (minoxidil) solution is minoxidil is used with other medications to treat high blood pressure (hypertension). This formulation utilizes a solution delivery system. Marketed by Vapor Pro Shoppe, Llc, this product is identified by NDC 84561-514 and is authorized under FDA application ANDA076239.

Identification & Billing

NDC Package Code
84561-514-00
Package Description
1 BOTTLE, DROPPER in 1 BOX / 60 mL in 1 BOTTLE, DROPPER
Product Code
84561-514
11-Digit Billing Format
84561051400
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elevate Hair Regrowth Treatment 5 Minoxidil Solution
Non-Proprietary Name
Minoxidil
Substance Name
Minoxidil
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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/mL
Pharmacologic Class
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
Vapor Pro Shoppe, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA076239
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-08-2024
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 84561-514-00 identifies a specific commercial package of 1 bottle, dropper in 1 box / 60 ml in 1 bottle, dropper of Elevate Hair Regrowth Treatment 5 Minoxidil Solution, a human over the counter drug labeled by Vapor Pro Shoppe, Llc. This solution 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 Vapor Pro Shoppe, Llc on July 08, 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 Vapor Pro Shoppe, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84561051400. 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)
84561-514-00
11-Digit CMS (5-4-2)
84561-0514-00

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