Babyliss Pro Protect Hand Sanitizer
NDC Package 78080-002-00

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.

Babyliss Pro Protect Hand Sanitizer is apply. Marketed by Makmac Inc, this product is identified by NDC 78080-002 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
78080-002-00
Package Description
12 BOTTLE in 1 BOX / 488 mL in 1 BOTTLE
Product Code
78080-002
11-Digit Billing Format
78080000200
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Babyliss Pro Protect Hand Sanitizer
Dosage Form
-
Usage Information
Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds. Recommended for repeated use. Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Makmac Inc
FDA Application #
part333E
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
09-25-2020
Listing Expiration
12-31-2021
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 78080-002-00 identifies a specific commercial package of 12 bottle in 1 box / 488 ml in 1 bottle of Babyliss Pro Protect Hand Sanitizer, labeled by Makmac Inc. 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 Makmac Inc on September 25, 2020. The current certification is valid through December 31, 2021.

How is this Makmac Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78080000200. 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)
78080-002-00
11-Digit CMS (5-4-2)
78080-0002-00

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