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  5. NDC Package Code: 49823-100-01 Zuragard Blue

NDC Package 49823-100-01 Zuragard Blue

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:
49823-100-01
Package Description:
25 POUCH in 1 CARTON / 10.5 mL in 1 POUCH
Product Code:
49823-100
Proprietary Name:
Zuragard Blue
Non-Proprietary Name:
Isopropyl Alcohol
Substance Name:
Isopropyl Alcohol
Usage Information:
Follow all directions for use▪use with care in premature infants or infants under 2 months of age.These products may cause irritation or chemical burns.▪do not use when the sponge is already wet upon opening the package▪discard the applicator after a single use along with any portion of thesolution which is not required to cover the prepped area. It is notnecessary to use the entire amount available.Getting Patient Ready for Solution:▪use in well-ventilated area▪do not microwave or heat the solution applicator▪apply to clean, completely dry, residue-free, intact skin▪when hair removal is necessary, use a surgical clipper on the morning ofthe surgery. If a wet shave is used, thoroughly remove all soap residues.Activating the Applicator:▪remove applicator from package; do not touch sponge▪hold the applicator with the sponge down. Depress the end cap/buttonto release the antiseptic, solution will flow into the sponge.When Applying Solution:▪completely wet the treatment area with antiseptic▪dry surgical sites (such as the abdomen or arm):use repeated back-and-forth strokes for 30 seconds▪moist surgical sites (such as inguinal fold):use repeated back-and-forth strokes for 2 minutes▪maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in.(457 cm2)▪do not allow solution to pool; tuck prep towels to absorb solution, andthen remove▪avoid getting solution into hairy areas. Wet hair is flammable. Hair maytake up to 1 hour to dry.After Applying Solution:▪to reduce the risk of fire, wait until solution is completely dry(minimum of 3 minutes on hairless skin; up to 1 hour in hair)While Waiting for Solution to Completely Dry:▪do not drape or use ignition source (e.g., cautery laser)▪check for pooled solution. Use sterile gauze to soak up pooled solution.Do not blot or wipe away because it may remove solution from skin.▪remove wet materials from prep area. Replace if necessary.After Solution is Completely Dry:▪to reduce the risk of fire, begin draping and/or using cautery only aftersolution is completely dry and all wet materials are removed▪if incise drapes are used, apply directly to dry prep▪apply dressing following standard practices
11-Digit NDC Billing Format:
49823010001
NDC to RxNorm Crosswalk:
  • RxCUI: 808520 - isopropyl alcohol 70 % Topical Solution
  • RxCUI: 808520 - isopropyl alcohol 0.7 ML/ML Topical Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Zurex Pharma, Inc.
    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):
  • ISOPROPYL ALCOHOL .7 mL/mL
    • Sample Package:
    No
    FDA Application Number:
    NDA210872
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-27-2023
    Listing Expiration Date:
    12-31-2024
    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
    49823-100-0225 POUCH in 1 BOX / 26 mL in 1 POUCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49823-100-01?

    The NDC Packaged Code 49823-100-01 is assigned to a package of 25 pouch in 1 carton / 10.5 ml in 1 pouch of Zuragard Blue, a human over the counter drug labeled by Zurex Pharma, Inc.. The product's dosage form is solution and is administered via topical form.

    Is NDC 49823-100 included in the NDC Directory?

    Yes, Zuragard Blue with product code 49823-100 is active and included in the NDC Directory. The product was first marketed by Zurex Pharma, Inc. on February 27, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 49823-100-01?

    The 11-digit format is 49823010001. 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
    5-3-249823-100-015-4-249823-0100-01