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  5. NDC Package Code: 57483-165-13 Regoxidine (for Men)

NDC Package 57483-165-13 Regoxidine (for Men)

Minoxidil Aerosol, Foam Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
57483-165-13
Package Description:
3 CAN in 1 CARTON / 60 g in 1 CAN (57483-165-01)
Product Code:
57483-165
Proprietary Name:
Regoxidine (for Men)
Non-Proprietary Name:
Minoxidil
Substance Name:
Minoxidil
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.
11-Digit NDC Billing Format:
57483016513
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Innovus Pharmaceuticals, Inc.
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(s):
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(es):
Sample Package:
No
FDA Application Number:
ANDA218616
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-03-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 57483-165-13?

The NDC Packaged Code 57483-165-13 is assigned to a package of 3 can in 1 carton / 60 g in 1 can (57483-165-01) of Regoxidine (for Men), a human over the counter drug labeled by Innovus Pharmaceuticals, Inc.. The product's dosage form is aerosol, foam and is administered via topical form.

Is NDC 57483-165 included in the NDC Directory?

Yes, Regoxidine (for Men) with product code 57483-165 is active and included in the NDC Directory. The product was first marketed by Innovus Pharmaceuticals, Inc. on May 03, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 57483-165-13?

The 11-digit format is 57483016513. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-257483-165-135-4-257483-0165-13