NDC Package 81280-003-01 Povidone-iodine

Swab Topical - View Billable Units, 11-Digit Format, RxNorm

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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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

Proprietary Name:

Povidone-iodine

Non-Proprietary Name:

Povidone-iodine

Substance Name:

Povidone-iodine

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.

11-Digit NDC Billing Format:

81280000301

NDC to RxNorm Crosswalk:

RxCUI: 1037205 - povidone-iodine 1 % Medicated Pad

RxCUI: 1037205 - povidone-iodine 10 MG/ML Medicated Pad

Product Type:

Human Otc Drug

Labeler Name:

Mazza Healthcare, Llc

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(s):

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

Sample Package:

FDA Application Number:

part333C

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

03-01-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

81280 - Mazza Healthcare, Llc
- 81280-003 - Povidone-iodine
  - 81280-003-01 - 500 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
81280-003-03	500 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 81280-003-01?

The NDC Packaged Code 81280-003-01 is assigned to a 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. The product's dosage form is swab and is administered via topical form.

Is NDC 81280-003 included in the NDC Directory?

Yes, Povidone-iodine with product code 81280-003 is active and included in the NDC Directory. The product was first marketed by Mazza Healthcare, Llc on March 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 81280-003-01?

The 11-digit format is 81280000301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	81280-003-01	5-4-2	81280-0003-01

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