Quality Choice Medicated Pads
NDC Package 63868-395-01

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.

Quality Choice Medicated Pads is as hemorrhoidal treatment for adults:• When practical, clean the affected area with mild soap and warm water and rinse thoroughly.• Gently dry by patting or blotting with toilet tissue or soft cloth before applying.• Gently apply to the affected area by patting and then discard.• Can be used up to six times daily or after each bowel movement.Children under 12 years of age: ask a doctor. Marketed by Quality Choice (chain Drug Marketing Association), this product is identified by NDC 63868-395 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
63868-395-01
Package Description
100 CLOTH in 1 JAR
Product Code
63868-395
11-Digit Billing Format
63868039501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quality Choice Medicated Pads
Dosage Form
-
Usage Information
As hemorrhoidal treatment for adults:• When practical, clean the affected area with mild soap and warm water and rinse thoroughly.• Gently dry by patting or blotting with toilet tissue or soft cloth before applying.• Gently apply to the affected area by patting and then discard.• Can be used up to six times daily or after each bowel movement.Children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Quality Choice (chain Drug Marketing Association)
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-12-2021
Listing Expiration
12-31-2024
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 63868-395-01 identifies a specific commercial package of 100 cloth in 1 jar of Quality Choice Medicated Pads, labeled by Quality Choice (chain Drug Marketing Association). This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Quality Choice (chain Drug Marketing Association) on May 12, 2021. The current certification is valid through December 31, 2024.

How is this Quality Choice (chain Drug Marketing Association) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868039501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
63868-395-01
11-Digit CMS (5-4-2)
63868-0395-01

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