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  5. NDC Package Code: 0115-1510-58 Naftifine Hydrochloride

NDC Package 0115-1510-58 Naftifine Hydrochloride

Gel 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:
0115-1510-58
Package Description:
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code:
0115-1510
Proprietary Name:
Naftifine Hydrochloride
Non-Proprietary Name:
Naftifine Hydrochloride
Substance Name:
Naftifine Hydrochloride
Usage Information:
Naftifine Hydrochloride Gel USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans1 and Epidermophyton floccosum.11Efficacy for this organism in this organ system was studied in fewer than 10 infections.
11-Digit NDC Billing Format:
00115151058
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
60 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 896106 - naftifine HCl 1 % Topical Gel
  • RxCUI: 896106 - naftifine hydrochloride 0.01 MG/MG Topical Gel
  • RxCUI: 896106 - naftifine hydrochloride 1 % Topical Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    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):
  • NAFTIFINE HYDROCHLORIDE 10 mg/g
    • Pharmacologic Class(es):
  • Allylamine Antifungal - [EPC] (Established Pharmacologic Class)
  • Allylamine - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA206165
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-20-2019
    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
    0115-1510-481 TUBE in 1 CARTON / 90 g in 1 TUBE
    0115-1510-631 TUBE in 1 CARTON / 40 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0115-1510-58?

    The NDC Packaged Code 0115-1510-58 is assigned to a package of 1 tube in 1 carton / 60 g in 1 tube of Naftifine Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is gel and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package.

    Is NDC 0115-1510 included in the NDC Directory?

    Yes, Naftifine Hydrochloride with product code 0115-1510 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on March 20, 2019 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 NDC billing unit for package 0115-1510-58?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 0115-1510-58?

    The 11-digit format is 00115151058. 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 4-4-2 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
    4-4-20115-1510-585-4-200115-1510-58