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  5. NDC Package Code: 58345-102-03 Solucion Antiseptica Dermoxine

NDC Package 58345-102-03 Solucion Antiseptica Dermoxine

Solucion Antiseptica Topica A Base De Alcohol Etilico Liquid 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:
58345-102-03
Package Description:
3 BOTTLE, PUMP in 1 BOX / 1000 mL in 1 BOTTLE, PUMP
Product Code:
58345-102
Proprietary Name:
Solucion Antiseptica Dermoxine
Non-Proprietary Name:
Solucion Antiseptica Topica A Base De Alcohol Etilico
Substance Name:
Alcohol; Chlorhexidine Gluconate
Usage Information:
This product is used as Antiseptic
11-Digit NDC Billing Format:
58345010203
Product Type:
Human Otc Drug
Labeler Name:
Key Qu�mica S.a. De C.v.
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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):
  • ALCOHOL 70 mL/100mL
  • CHLORHEXIDINE GLUCONATE .97 mg/100mL
    • Pharmacologic Class(es):
  • Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    505G(a)(3)
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    04-04-2024
    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
    58345-102-0112 BOTTLE, PUMP in 1 BOX / 500 mL in 1 BOTTLE, PUMP
    58345-102-023 BOTTLE in 1 BOX / 1000 mL in 1 BOTTLE
    58345-102-044 BOTTLE in 1 BOX / 4000 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58345-102-03?

    The NDC Packaged Code 58345-102-03 is assigned to a package of 3 bottle, pump in 1 box / 1000 ml in 1 bottle, pump of Solucion Antiseptica Dermoxine, a human over the counter drug labeled by Key Qu�mica S.a. De C.v.. The product's dosage form is liquid and is administered via topical form.

    Is NDC 58345-102 included in the NDC Directory?

    Yes, Solucion Antiseptica Dermoxine with product code 58345-102 is active and included in the NDC Directory. The product was first marketed by Key Qu�mica S.a. De C.v. on April 04, 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 58345-102-03?

    The 11-digit format is 58345010203. 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
    5-3-258345-102-035-4-258345-0102-03