Naftifine Hydrochloride Gel
NDC Package 51672-1376-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Naftifine Hydrochloride gel is uSP, 2% is indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. This formulation utilizes a gel delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1376 and is authorized under FDA application ANDA208201.

Identification & Billing

NDC Package Code
51672-1376-3
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
51672-1376
11-Digit Billing Format
51672137603
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naftifine Hydrochloride
Non-Proprietary Name
Naftifine Hydrochloride
Substance Name
Naftifine Hydrochloride
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
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 20 mg/g
Pharmacologic Class
Usage Information
Naftifine hydrochloride gel USP, 2% is indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208201
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51672-1376). Click a package code to view its specific billing and regulatory data.

51672-1376-6
1 TUBE in 1 CARTON / 45 g in 1 TUBE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51672-1376-3 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Naftifine Hydrochloride, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This gel is formulated for topical use and contains naftifine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sun Pharmaceutical Industries, Inc. on April 01, 2023. The current certification is valid through December 31, 2027.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672137603. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
51672-1376-3
11-Digit CMS (5-4-2)
51672-1376-03

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.