Ultra Prep Alcohol Prep Pads Cloth
NDC Package 83878-101-11

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

Package Information

Ultra Prep Alcohol Prep Pads (isopropyl alcohol) cloths is wipe injection site vigorously and discard after single use. This formulation utilizes a cloth delivery system. Marketed by Quality Medical Products Usa, Inc., this product is identified by NDC 83878-101 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
83878-101-11
Package Description
100 PACKET in 1 BOX / 1 PACKAGE in 1 PACKET / .45 mL in 1 PACKAGE
Product Code
83878-101
11-Digit Billing Format
83878010111
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ultra Prep Alcohol Prep Pads
Non-Proprietary Name
Isopropyl Alcohol
Substance Name
Isopropyl Alcohol
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
ISOPROPYL ALCOHOL 70 mL/100mL
Usage Information
Wipe injection site vigorously and discard after single use.

Regulatory & Marketing

Labeler Name
Quality Medical Products Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 83878-101-11 identifies a specific commercial package of 100 packet in 1 box / 1 package in 1 packet / .45 ml in 1 package of Ultra Prep Alcohol Prep Pads, a human over the counter drug labeled by Quality Medical Products Usa, Inc.. This cloth is formulated for topical use and contains isopropyl alcohol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Quality Medical Products Usa, Inc. on July 15, 2024. The current certification is valid through December 31, 2026.

How is this Quality Medical Products Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83878010111. 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)
83878-101-11
11-Digit CMS (5-4-2)
83878-0101-11

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