Purprep Sponge
NDC Package 54365-014-41

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

Purprep (povidone iodine and isopropyl alcohol) sponges is for the preparation of the patient's skin prior to surgery. This formulation utilizes a sponge delivery system. Marketed by Carefusion 213 Llc, this product is identified by NDC 54365-014 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
54365-014-41
Package Description
1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
Product Code
54365-014
11-Digit Billing Format
54365001441
RxNorm Crosswalk
  • RxCUI: 1052725 - povidone-iodine 8.3 % / isopropyl alcohol 72.5 % Topical Solution
  • RxCUI: 1052725 - isopropyl alcohol 0.725 ML/ML / povidone-iodine 83 MG/ML Topical Solution
  • RxCUI: 1052725 - isopropyl alcohol 72.5 % / povidone-iodine 8.3 % Topical Solution

Clinical Specifications

Proprietary Name
Purprep
Non-Proprietary Name
Povidone Iodine And Isopropyl Alcohol
Substance Name
Isopropyl Alcohol; Povidone-iodine
Dosage Form
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
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)
Usage Information
For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Regulatory & Marketing

Labeler Name
Carefusion 213 Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-09-2020
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 (54365-014). Click a package code to view its specific billing and regulatory data.

54365-014-42
1 APPLICATOR in 1 POUCH / 26 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 54365-014-41 identifies a specific commercial package of 1 applicator in 1 pouch / 10.5 ml in 1 applicator of Purprep, a human over the counter drug labeled by Carefusion 213 Llc. This sponge is formulated for topical use and contains isopropyl alcohol; 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 Carefusion 213 Llc on April 09, 2020. The current certification is valid through December 31, 2026.

How is this Carefusion 213 Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54365001441. 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)
54365-014-41
11-Digit CMS (5-4-2)
54365-0014-41

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