Metronidazole Topical Gel
NDC Package 69007-835-45

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 discontinued by the firm.

Metronidazole Topical Gel is a . Marketed by Owen Laboratories, this product is identified by NDC 69007-835 and is authorized under FDA application NDA019737.

Identification & Billing

NDC Package Code
69007-835-45
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
69007-835
11-Digit Billing Format
69007083545
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM

Clinical Specifications

Proprietary Name
Metronidazole Topical Gel
Dosage Form
-

Regulatory & Marketing

Labeler Name
Owen Laboratories
FDA Application #
NDA019737
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
03-01-2014
End Marketing Date
12-31-2017
Listing Expiration
12-31-2017
Exclude Flag
D
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 69007-835-45 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Metronidazole Topical Gel, labeled by Owen Laboratories. 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 Owen Laboratories on March 01, 2014. The current certification is valid through December 31, 2017.

How is this Owen Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69007083545. 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)
69007-835-45
11-Digit CMS (5-4-2)
69007-0835-45

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