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  5. NDC Package Code: 57483-535-03 Regoxidine

NDC Package 57483-535-03 Regoxidine

Minoxidil Solution 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:
57483-535-03
Package Description:
3 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code:
57483-535
Proprietary Name:
Regoxidine
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:
57483053503
NDC to RxNorm Crosswalk:
  • RxCUI: 2548832 - Regoxidine 5 % Topical Solution
  • RxCUI: 2548832 - minoxidil 50 MG/ML Topical Solution [Regoxidine]
  • RxCUI: 2548832 - Regoxidine 50 MG/ML Topical Solution
  • RxCUI: 311724 - minoxidil 5 % Topical Solution
  • RxCUI: 311724 - minoxidil 50 MG/ML Topical Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Innovus Pharmaceuticals Inc.
    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(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 3 g/60mL
    • Pharmacologic Class(es):
  • Arteriolar Vasodilation - [PE] (Physiologic Effect)
  • Arteriolar Vasodilator - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076239
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-20-2021
    Listing Expiration Date:
    12-31-2024
    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 57483-535-03?

    The NDC Packaged Code 57483-535-03 is assigned to a package of 3 bottle in 1 carton / 60 ml in 1 bottle of Regoxidine, a human over the counter drug labeled by Innovus Pharmaceuticals Inc.. The product's dosage form is solution and is administered via topical form.

    Is NDC 57483-535 included in the NDC Directory?

    Yes, Regoxidine with product code 57483-535 is active and included in the NDC Directory. The product was first marketed by Innovus Pharmaceuticals Inc. on May 20, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 57483-535-03?

    The 11-digit format is 57483053503. 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
    5-3-257483-535-035-4-257483-0535-03