Oxiconazole Nitrate Cream
NDC Package 0168-0358-30

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

Oxiconazole Nitrate cream is oxiconazole is used to treat skin infections such as athlete's foot, jock itch and ringworm. This formulation utilizes a cream delivery system. Marketed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc, this product is identified by NDC 0168-0358 and is authorized under FDA application NDA019828.

Identification & Billing

NDC Package Code
0168-0358-30
Package Description
30 g in 1 TUBE
Product Code
0168-0358
11-Digit Billing Format
00168035830
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxiconazole Nitrate
Non-Proprietary Name
Oxiconazole Nitrate
Substance Name
Oxiconazole Nitrate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
OXICONAZOLE NITRATE 10 mg/g
Pharmacologic Class
Usage Information
Oxiconazole is used to treat skin infections such as athlete's foot, jock itch and ringworm. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Oxiconazole is an azole antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019828
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-09-2016
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 (0168-0358). Click a package code to view its specific billing and regulatory data.

0168-0358-60
60 g in 1 TUBE
0168-0358-90
90 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 0168-0358-30 identifies a specific commercial package of 30 g in 1 tube of Oxiconazole Nitrate, a human prescription drug labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc. This cream is formulated for topical use and contains oxiconazole nitrate 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc on March 09, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Oxiconazole is used to treat skin infections such as athlete's foot, jock itch and ringworm. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Oxiconazole is an azole antifungal that works by preventing the growth of fungus.

How is this E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168035830. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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 (4-4-2)
0168-0358-30
11-Digit CMS (5-4-2)
00168-0358-30

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