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  5. NDC Package Code: 58443-0523-3 United Spirit Of America Hand Sanitizer

NDC Package 58443-0523-3 United Spirit Of America Hand Sanitizer

Ethyl Alcohol Gel 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:
58443-0523-3
Package Description:
88.7 mL in 1 BOTTLE
Product Code:
58443-0523
Proprietary Name:
United Spirit Of America Hand Sanitizer
Non-Proprietary Name:
Ethyl Alcohol
Substance Name:
Alcohol
Usage Information:
Wet hands thoroughly with product and allow to dry without wiping.For children under 6, use only under adult supervision.
11-Digit NDC Billing Format:
58443052303
Product Type:
Human Otc Drug
Labeler Name:
Prime Enterprises
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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):
  • ALCOHOL 606.2 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    part333A
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    06-13-2019
    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 58443-0523-3?

    The NDC Packaged Code 58443-0523-3 is assigned to a package of 88.7 ml in 1 bottle of United Spirit Of America Hand Sanitizer, a human over the counter drug labeled by Prime Enterprises. The product's dosage form is gel and is administered via topical form.

    Is NDC 58443-0523 included in the NDC Directory?

    Yes, United Spirit Of America Hand Sanitizer with product code 58443-0523 is active and included in the NDC Directory. The product was first marketed by Prime Enterprises on June 13, 2019 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 58443-0523-3?

    The 11-digit format is 58443052303. 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 5-4-1 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
    5-4-158443-0523-35-4-258443-0523-03