Povidone-iodine Prep Pad Solution
NDC Package 63517-400-83

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

Package Information

Povidone-iodine Prep Pad (povidone-iodine) solution is • clean the affected area • apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first. This formulation utilizes a solution delivery system. Marketed by Cardinal Health 200, Inc., this product is identified by NDC 63517-400 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
63517-400-83
Package Description
10 BOX in 1 CARTON / 100 POUCH in 1 BOX / .56 g in 1 POUCH
Product Code
63517-400
11-Digit Billing Format
63517040083
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Povidone-iodine Prep Pad
Non-Proprietary Name
Povidone-iodine
Substance Name
Povidone-iodine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
POVIDONE-IODINE 10 g/100g
Usage Information
• clean the affected area • apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first

Regulatory & Marketing

Labeler Name
Cardinal Health 200, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-05-2016
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 63517-400-83 identifies a specific commercial package of 10 box in 1 carton / 100 pouch in 1 box / .56 g in 1 pouch of Povidone-iodine Prep Pad, a human over the counter drug labeled by Cardinal Health 200, Inc.. This solution is formulated for topical use and contains povidone-iodine 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 Cardinal Health 200, Inc. on August 05, 2016. The current certification is valid through December 31, 2026.

How is this Cardinal Health 200, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63517040083. 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)
63517-400-83
11-Digit CMS (5-4-2)
63517-0400-83

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