Oxiconazole Nitrate Powder
NDC Package 42765-002-10

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Oxiconazole Nitrate powders is oxiconazole is used to treat skin infections such as athlete's foot, jock itch and ringworm. This formulation utilizes a powder delivery system. Marketed by Metrochem Api Private Limited, this product is identified by NDC 42765-002.

Identification & Billing

NDC Package Code
42765-002-10
Package Description
10 kg in 1 DRUM
Product Code
42765-002
11-Digit Billing Format
42765000210

Clinical Specifications

Proprietary Name
Oxiconazole Nitrate
Non-Proprietary Name
Oxiconazole Nitrate
Substance Name
Oxiconazole
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
OXICONAZOLE 1 kg/kg
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
Metrochem Api Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-01-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (42765-002). Click a package code to view its specific billing and regulatory data.

42765-002-25
25 kg in 1 DRUM

* 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 42765-002-10 identifies a specific commercial package of 10 kg in 1 drum of Oxiconazole Nitrate (UNFINISHED drug), a bulk ingredient labeled by Metrochem Api Private Limited. This powder is formulated for use and contains oxiconazole 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 Metrochem Api Private Limited on September 01, 2019. The current certification is valid through December 31, 2026.

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 Metrochem Api Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42765000210. 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 (5-3-2)
42765-002-10
11-Digit CMS (5-4-2)
42765-0002-10

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