Henry Schein Povidone-iodine Prep Pad Swab
NDC Package 0404-0121-01

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

Package Information

Henry Schein Povidone-iodine Prep Pad (povidone-iodine) swabs is clean area. This formulation utilizes a swab delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-0121 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
0404-0121-01
Package Description
8000 POUCH in 1 CASE / .5 mL in 1 POUCH
Product Code
0404-0121
11-Digit Billing Format
00404012101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Henry Schein Povidone-iodine Prep Pad
Non-Proprietary Name
Povidone-iodine
Substance Name
Povidone-iodine
Dosage Form
Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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)
POVIDONE-IODINE 1 g/100mL
Usage Information
Clean area. Apply to the operative site prior to surgery

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-22-2019
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 0404-0121-01 identifies a specific commercial package of 8000 pouch in 1 case / .5 ml in 1 pouch of Henry Schein Povidone-iodine Prep Pad, a human over the counter drug labeled by Henry Schein, Inc.. This swab 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 Henry Schein, Inc. on October 22, 2019. The current certification is valid through December 31, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404012101. 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 (4-4-2)
0404-0121-01
11-Digit CMS (5-4-2)
00404-0121-01

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