Hand Sanitizer Gel
NDC Package 78283-101-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hand Sanitizer Gel is a . Marketed by Berioska S.l., this product is identified by NDC 78283-101 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
78283-101-01
Package Description
300 mL in 1 BOTTLE
Product Code
78283-101
11-Digit Billing Format
78283010101

Clinical Specifications

Proprietary Name
Hand Sanitizer Gel
Dosage Form
-

Regulatory & Marketing

Labeler Name
Berioska S.l.
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-20-2022
End Marketing Date
12-31-2023
Listing Expiration
12-31-2023
Exclude Flag
D
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 78283-101-01 identifies a specific commercial package of 300 ml in 1 bottle of Hand Sanitizer Gel, labeled by Berioska S.l.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Berioska S.l. on January 20, 2022. The current certification is valid through December 31, 2023.

How is this Berioska S.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78283010101. 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)
78283-101-01
11-Digit CMS (5-4-2)
78283-0101-01

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