Hand Sanitizer
NDC Package 78522-101-00

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 inactivated by the FDA.

Hand Sanitizer is directions. Marketed by Northmed, this product is identified by NDC 78522-101 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78522-101-00
Package Description
80 mL in 1 BOTTLE
Product Code
78522-101
11-Digit Billing Format
78522010100

Clinical Specifications

Proprietary Name
Hand Sanitizer
Dosage Form
-
Usage Information
Directions. Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Northmed
FDA Application #
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
03-15-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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 78522-101-00 identifies a specific commercial package of 80 ml in 1 bottle of Hand Sanitizer, labeled by Northmed. 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 Northmed on March 15, 2021. The current certification is valid through December 31, 2022.

How is this Northmed product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78522010100. 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)
78522-101-00
11-Digit CMS (5-4-2)
78522-0101-00

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