Sanipower Hand Sanitizer
NDC Package 80133-003-10

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.

Sanipower Hand Sanitizer is apply 3-5mL (approx. Marketed by Ivero D.o.o., this product is identified by NDC 80133-003 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80133-003-10
Package Description
1000 mL in 1 BOTTLE
Product Code
80133-003
11-Digit Billing Format
80133000310
RxNorm Crosswalk
  • RxCUI: 2396264 - benzalkonium chloride 0.0165 % / ethanol 55 % / isopropyl alcohol 15 % Topical Gel
  • RxCUI: 2396264 - benzalkonium chloride 0.000165 MG/MG / ethanol 0.55 ML/ML / isopropyl alcohol 0.15 ML/ML Topical Gel

Clinical Specifications

Proprietary Name
Sanipower Hand Sanitizer
Dosage Form
-
Usage Information
Apply 3-5mL (approx. 1 tsp) of product to dry hands and wrists and rub until dry (at least 30 seconds). Period required for biocidal effect: 30-60 seconds.For external use only.Supervise children under 6 years of age when using product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Ivero D.o.o.
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
09-09-2020
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 80133-003-10 identifies a specific commercial package of 1000 ml in 1 bottle of Sanipower Hand Sanitizer, labeled by Ivero D.o.o.. 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 Ivero D.o.o. on September 09, 2020. The current certification is valid through December 31, 2021.

How is this Ivero D.o.o. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80133000310. 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)
80133-003-10
11-Digit CMS (5-4-2)
80133-0003-10

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