Repara
NDC Package 68345-818-26

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Repara is Indications: Intended to help protect chafed skin or minor skin irritations, as well as to prevent diaper dermatitis.Precautions: FOR EXTERNAL USE ONLY. Marketed by Pss World Medical, Inc., this product is identified by NDC 68345-818 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
68345-818-26
Package Description
114 g in 1 TUBE
Product Code
68345-818
11-Digit Billing Format
68345081826
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Repara
Dosage Form
-
Usage Information
Indications: Intended to help protect chafed skin or minor skin irritations, as well as to prevent diaper dermatitis.Precautions: FOR EXTERNAL USE ONLY. Discontinue use should irritation occur. Do not use on deep puncture wounds, animal bites, and serious burns.Frequency: Daily.UsesHelps prevent diaper dermatitis.Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

Regulatory & Marketing

Labeler Name
Pss World Medical, Inc.
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-06-2014
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68345-818). Click a package code to view its specific billing and regulatory data.

68345-818-25
144 PACKAGE in 1 CARTON / 5 g in 1 PACKAGE

* 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 68345-818-26 identifies a specific commercial package of 114 g in 1 tube of Repara, labeled by Pss World Medical, 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 Pss World Medical, Inc. on August 06, 2014. The current certification is valid through December 31, 2017.

How is this Pss World Medical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68345081826. 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)
68345-818-26
11-Digit CMS (5-4-2)
68345-0818-26

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