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  5. NDC Package Code: 54365-401-29 Chloraprep Swabstick

NDC Package 54365-401-29 Chloraprep Swabstick

Chlorhexidine Gluconate And Isopropyl Alcohol Solution Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
54365-401-29
Package Description:
40 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR
Product Code:
54365-401
Proprietary Name:
Chloraprep Swabstick
Non-Proprietary Name:
Chlorhexidine Gluconate And Isopropyl Alcohol
Substance Name:
Chlorhexidine Gluconate; Isopropyl Alcohol
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.
11-Digit NDC Billing Format:
54365040129
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Carefusion 213 Llc
    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(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):
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
    • Pharmacologic Class(es):
  • Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    NDA021555
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-13-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    54365-401-2848 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54365-401-29?

    The NDC Packaged Code 54365-401-29 is assigned to a package of 40 pouch in 1 carton / 3 applicator in 1 pouch / 5.25 ml in 1 applicator of Chloraprep Swabstick, a human over the counter drug labeled by Carefusion 213 Llc. The product's dosage form is solution and is administered via topical form.

    Is NDC 54365-401 included in the NDC Directory?

    Yes, Chloraprep Swabstick with product code 54365-401 is active and included in the NDC Directory. The product was first marketed by Carefusion 213 Llc on May 13, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 54365-401-29?

    The 11-digit format is 54365040129. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-254365-401-295-4-254365-0401-29