Hand Sanitizer
NDC Package 78428-250-01

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 is a . Marketed by Laboratorios Farmaceutico Y De Cosmetica Pineda De Colombia Sas, this product is identified by NDC 78428-250 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78428-250-01
Package Description
250 mL in 1 BOTTLE
Product Code
78428-250
11-Digit Billing Format
78428025001

Clinical Specifications

Proprietary Name
Hand Sanitizer
Dosage Form
-

Regulatory & Marketing

Labeler Name
Laboratorios Farmaceutico Y De Cosmetica Pineda De Colombia Sas
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
03-30-2020
End Marketing Date
06-15-2020
Listing Expiration
06-15-2020
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 78428-250-01 identifies a specific commercial package of 250 ml in 1 bottle of Hand Sanitizer, labeled by Laboratorios Farmaceutico Y De Cosmetica Pineda De Colombia Sas. 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 Laboratorios Farmaceutico Y De Cosmetica Pineda De Colombia Sas on March 30, 2020. The current certification is valid through June 15, 2020.

How is this Laboratorios Farmaceutico Y De Cosmetica Pineda De Colombia Sas product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78428025001. 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)
78428-250-01
11-Digit CMS (5-4-2)
78428-0250-01

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