Sterite Element
NDC Package 81576-2000-2

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.

Sterite Element is uSESHAND AND SURGACE DISINFECTANT TO HELP REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASES. Marketed by Palvi Mexico, S.a. De C.v., this product is identified by NDC 81576-2000 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
81576-2000-2
Package Description
1000 mL in 1 BOTTLE, PLASTIC
Product Code
81576-2000
11-Digit Billing Format
81576200002

Clinical Specifications

Proprietary Name
Sterite Element
Dosage Form
-
Usage Information
USESHAND AND SURGACE DISINFECTANT TO HELP REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASES

Regulatory & Marketing

Labeler Name
Palvi Mexico, S.a. De C.v.
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
02-16-2021
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 81576-2000-2 identifies a specific commercial package of 1000 ml in 1 bottle, plastic of Sterite Element, labeled by Palvi Mexico, S.a. De C.v.. 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 Palvi Mexico, S.a. De C.v. on February 16, 2021. The current certification is valid through December 31, 2022.

How is this Palvi Mexico, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81576200002. 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 (5-4-1)
81576-2000-2
11-Digit CMS (5-4-2)
81576-2000-02

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