Metronidazole Topical Cream
NDC Package 72189-306-45

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Marketed by Directrx, this product is identified by NDC 72189-306 and is authorized under FDA application NDA020531.

Identification & Billing

NDC Package Code
72189-306-45
Package Description
45 g in 1 TUBE
Product Code
72189-306
11-Digit Billing Format
72189030645
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metronidazole Topical Cream
Dosage Form
-
Usage Information
Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Regulatory & Marketing

Labeler Name
Directrx
FDA Application #
NDA020531
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
01-18-2022
Listing Expiration
12-31-2024
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-306-45 identifies a specific commercial package of 45 g in 1 tube of Metronidazole Topical Cream, labeled by Directrx. This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Directrx on January 18, 2022. The current certification is valid through December 31, 2024.

How is this Directrx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189030645. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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 (5-3-2)
72189-306-45
11-Digit CMS (5-4-2)
72189-0306-45

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