Steral Antiseptic Sanitizing Wipe
NDC Package 82045-050-01

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 inactivated by the FDA.

Steral Antiseptic Sanitizing Wipe is • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing • discard after use • do not dispose of wipes in flush toilet. Marketed by Steral Products Limited, this product is identified by NDC 82045-050 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
82045-050-01
Package Description
1 PACKAGE in 1 PACKET / 2.9 mL in 1 PACKAGE
Product Code
82045-050
11-Digit Billing Format
82045005001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Steral Antiseptic Sanitizing Wipe
Dosage Form
-
Usage Information
• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing • discard after use • do not dispose of wipes in flush toilet

Regulatory & Marketing

Labeler Name
Steral Products Limited
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
07-12-2021
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 82045-050-01 identifies a specific commercial package of 1 package in 1 packet / 2.9 ml in 1 package of Steral Antiseptic Sanitizing Wipe, labeled by Steral Products Limited. 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 Steral Products Limited on July 12, 2021. The current certification is valid through December 31, 2022.

How is this Steral Products Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82045005001. 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)
82045-050-01
11-Digit CMS (5-4-2)
82045-0050-01

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