Chloraprep Swabstick Solution
NDC Package 54365-401-28

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

Chloraprep Swabstick (chlorhexidine gluconate and isopropyl alcohol) solution is use with care in premature infants or infants under 2 months of age. This formulation utilizes a solution delivery system. Marketed by Carefusion 213 Llc, this product is identified by NDC 54365-401 and is authorized under FDA application NDA021555.

Identification & Billing

NDC Package Code
54365-401-28
Package Description
48 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
Product Code
54365-401
11-Digit Billing Format
54365040128
RxNorm Crosswalk
  • RxCUI: 1918214 - chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated Pad
  • RxCUI: 1918214 - chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad
  • RxCUI: 1918214 - chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Swab

Clinical Specifications

Proprietary Name
Chloraprep Swabstick
Non-Proprietary Name
Chlorhexidine Gluconate And Isopropyl Alcohol
Substance Name
Chlorhexidine Gluconate; Isopropyl Alcohol
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)
Pharmacologic Class
Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
Usage Information
Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.maximal treatment area usingone single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2) three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm 2) tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.completely wet the treatment area with antisepticdry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 2 minutes). Allow the area to air dry for approximately 1 minute. Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

Regulatory & Marketing

Labeler Name
Carefusion 213 Llc
Product Type
Human Otc Drug
FDA Application #
NDA021555
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-13-2024
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 (54365-401). Click a package code to view its specific billing and regulatory data.

54365-401-29
40 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 5.25 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 54365-401-28 identifies a specific commercial package of 48 pouch in 1 carton / 1 applicator in 1 pouch / 1.75 ml in 1 applicator of Chloraprep Swabstick, a human over the counter drug labeled by Carefusion 213 Llc. This solution is formulated for topical use and contains chlorhexidine gluconate; isopropyl alcohol 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 May 13, 2024. 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: 54365040128. 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)
54365-401-28
11-Digit CMS (5-4-2)
54365-0401-28

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