Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules
NDC Package 43553-0000-0

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.

Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules is • Twist off sealed tab • Apply contents directly to the area to be cleansed • Contents may be poured onto an Optipore® Wound Cleansing Sponge or sterile gauze pad, then gently cleanse. Marketed by Convatec Inc, this product is identified by NDC 43553-0000 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
43553-0000-0
Package Description
24 BOTTLE, UNIT-DOSE in 1 CARTON / 20 mL in 1 BOTTLE, UNIT-DOSE
Product Code
43553-0000
11-Digit Billing Format
43553000000
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules
Dosage Form
-
Usage Information
• Twist off sealed tab • Apply contents directly to the area to be cleansed • Contents may be poured onto an Optipore® Wound Cleansing Sponge or sterile gauze pad, then gently cleanse

Regulatory & Marketing

Labeler Name
Convatec Inc
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
10-26-2017
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 43553-0000-0 identifies a specific commercial package of 24 bottle, unit-dose in 1 carton / 20 ml in 1 bottle, unit-dose of Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules, labeled by Convatec 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 Convatec Inc on October 26, 2017. The current certification is valid through December 31, 2022.

How is this Convatec Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43553000000. 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)
43553-0000-0
11-Digit CMS (5-4-2)
43553-0000-00

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