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  5. NDC Package Code: 55758-039-06 Parche Leon

NDC Package 55758-039-06 Parche Leon

Capsaicin,Camphor,Menthol Patch 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:
55758-039-06
Package Description:
6 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (55758-039-01)
Product Code:
55758-039
Proprietary Name:
Parche Leon
Non-Proprietary Name:
Capsaicin, Camphor, Menthol
Substance Name:
Camphor (synthetic); Capsaicin; Menthol, Unspecified Form
Usage Information:
Adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor clean and dry affected arearemove patch from filmapply sticky side of patch to affected areause one patch at a timeleave patch on affected area for up to 8-hours at a time
11-Digit NDC Billing Format:
55758003906
Product Type:
Human Otc Drug
Labeler Name:
Pharmadel Llc
Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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):
  • CAMPHOR (SYNTHETIC) 3 g/1
  • CAPSAICIN .025 g/1
  • MENTHOL, UNSPECIFIED FORM 1.25 g/1
    • Sample Package:
    No
    FDA Application Number:
    part348
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    02-28-2020
    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
    55758-039-011 PATCH in 1 POUCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55758-039-06?

    The NDC Packaged Code 55758-039-06 is assigned to a package of 6 pouch in 1 carton / 1 patch in 1 pouch (55758-039-01) of Parche Leon, a human over the counter drug labeled by Pharmadel Llc. The product's dosage form is patch and is administered via topical form.

    Is NDC 55758-039 included in the NDC Directory?

    Yes, Parche Leon with product code 55758-039 is active and included in the NDC Directory. The product was first marketed by Pharmadel Llc on February 28, 2020 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 55758-039-06?

    The 11-digit format is 55758003906. 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
    5-3-255758-039-065-4-255758-0039-06