Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub Solution
NDC Package 67326-352-08

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

Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub (povidone-iodine) solution is patient preoperative skin preparation:Clean the areaApply product to the operative site prior to surgeryScrub thoroughly for 5 minutesRinse off with a sterile gauze saturated with waterSurgical hand scrub:Clean under nails with a nail pick. This formulation utilizes a solution delivery system. Marketed by Degasa Sa De Cv, this product is identified by NDC 67326-352 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
67326-352-08
Package Description
48 BOTTLE in 1 CASE / 118 mL in 1 BOTTLE
Product Code
67326-352
11-Digit Billing Format
67326035208

Clinical Specifications

Proprietary Name
Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub
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 75 mg/mL
Usage Information
Patient preoperative skin preparation:Clean the areaApply product to the operative site prior to surgeryScrub thoroughly for 5 minutesRinse off with a sterile gauze saturated with waterSurgical hand scrub:Clean under nails with a nail pick. Nail should be maintained with a 1 millimeter free edgeWet hands and forearmsApply 5 millileters (teaspoonful) or palmfull to hands and forearmsScub thoroughly for 5 minutes with a sterile brushPaying particular attention to the nails, cuticles, and interdigital spacesRinse and repeat scrub

Regulatory & Marketing

Labeler Name
Degasa Sa De Cv
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-13-2015
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 (67326-352). Click a package code to view its specific billing and regulatory data.

67326-352-03
24 BOTTLE in 1 CASE / 474 mL in 1 BOTTLE
67326-352-05
12 BOTTLE in 1 CASE / 948 mL in 1 BOTTLE
67326-352-06
24 BOTTLE in 1 CASE / 237 mL in 1 BOTTLE
67326-352-07
48 BOTTLE in 1 CASE / 59 mL in 1 BOTTLE

* 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 67326-352-08 identifies a specific commercial package of 48 bottle in 1 case / 118 ml in 1 bottle of Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub, a human over the counter drug labeled by Degasa Sa De Cv. 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 Degasa Sa De Cv on August 13, 2015. The current certification is valid through December 31, 2026.

How is this Degasa Sa De Cv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67326035208. 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)
67326-352-08
11-Digit CMS (5-4-2)
67326-0352-08

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