Povidone-iodine Swab
NDC Package 81280-003-01

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

Povidone-iodine swabs is clean the affected area for preparation of the skin prior to surgery, apply product to the operative site apply product on the area 1-3 times daily. This formulation utilizes a swab delivery system. Marketed by Mazza Healthcare, Llc, this product is identified by NDC 81280-003 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
81280-003-01
Package Description
500 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR
Product Code
81280-003
11-Digit Billing Format
81280000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Povidone-iodine
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 mg/mL
Usage Information
Clean the affected area for preparation of the skin prior to surgery, apply product to the operative site apply product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Regulatory & Marketing

Labeler Name
Mazza Healthcare, Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81280-003). Click a package code to view its specific billing and regulatory data.

81280-003-03
500 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR

* 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 81280-003-01 identifies a specific commercial package of 500 pouch in 1 carton / 1 applicator in 1 pouch / 2.5 ml in 1 applicator of Povidone-iodine, a human over the counter drug labeled by Mazza Healthcare, Llc. 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 Mazza Healthcare, Llc on March 01, 2021. The current certification is valid through December 31, 2026.

How is this Mazza Healthcare, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81280000301. 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)
81280-003-01
11-Digit CMS (5-4-2)
81280-0003-01

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