Prep Solution
NDC Package 67326-350-07

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

Prep Solution (povidone-iodine) solution is for preparation of the skin prior to surgery:Apply product to the operative site prior to surgeryAs a first aid antiseptic:Clean the affected areaApply a small amount of this product on the area 1-3 times daily. This formulation utilizes a solution delivery system. Marketed by Degasa Sa De Cv, this product is identified by NDC 67326-350 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
67326-350-07
Package Description
237 mL in 1 BOTTLE
Product Code
67326-350
11-Digit Billing Format
67326035007

Clinical Specifications

Proprietary Name
Prep Solution Topical Antiseptic Microbicide
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 100 mg/mL
Usage Information
For preparation of the skin prior to surgery:Apply product to the operative site prior to surgeryAs a first aid antiseptic:Clean the affected areaApply a small amount of this product on the area 1-3 times daily

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
01-01-2007
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 (67326-350). Click a package code to view its specific billing and regulatory data.

67326-350-04
948 mL in 1 BOTTLE
67326-350-05
59 mL in 1 BOTTLE
67326-350-06
118 mL in 1 BOTTLE
67326-350-08
474 mL in 1 BOTTLE
67326-350-09
3785 mL in 1 JUG
67326-350-10
89 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 67326-350-07 identifies a specific commercial package of 237 ml in 1 bottle of Prep Solution Topical Antiseptic Microbicide, 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 January 01, 2007. 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: 67326035007. 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)
67326-350-07
11-Digit CMS (5-4-2)
67326-0350-07

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