Amoray 70% Ethyl Alcohol Hand Sanitizer Fresh Citrus Gel
NDC Package 51628-4435-1

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

Package Information

Amoray 70% Ethyl Alcohol Hand Sanitizer Fresh Citrus (ethyl alcohol) gel is pump as needed into your palms and thoroughly spread on both hands.Rub into skin until dry. This formulation utilizes a gel delivery system. Marketed by My Imports Usa Llc, this product is identified by NDC 51628-4435 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
51628-4435-1
Package Description
53 mL in 1 BOTTLE
Product Code
51628-4435
11-Digit Billing Format
51628443501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amoray 70% Ethyl Alcohol Hand Sanitizer Fresh Citrus
Non-Proprietary Name
Ethyl Alcohol
Substance Name
Alcohol
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
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 70 mL/100mL
Usage Information
Pump as needed into your palms and thoroughly spread on both hands.Rub into skin until dry.

Regulatory & Marketing

Labeler Name
My Imports Usa Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
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 51628-4435-1 identifies a specific commercial package of 53 ml in 1 bottle of Amoray 70% Ethyl Alcohol Hand Sanitizer Fresh Citrus, a human over the counter drug labeled by My Imports Usa Llc. This gel is formulated for topical use and contains alcohol 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 My Imports Usa Llc on July 08, 2024. The current certification is valid through December 31, 2026.

How is this My Imports Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51628443501. 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 (5-4-1)
51628-4435-1
11-Digit CMS (5-4-2)
51628-4435-01

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