Metronidazole
NDC Package 67457-697-10

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 is an antibiotic that is used to treat a wide variety of infections. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-697 and is authorized under FDA application ANDA205531.

Identification & Billing

NDC Package Code
67457-697-10
Package Description
1 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 100 mL in 1 BAG
Product Code
67457-697
11-Digit Billing Format
67457069710

Clinical Specifications

Proprietary Name
Metronidazole
Dosage Form
-
Usage Information
Metronidazole is an antibiotic that is used to treat a wide variety of infections. It works by stopping the growth of certain bacteria and parasites. This antibiotic treats only certain bacterial and parasitic infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Metronidazole may also be used with other medications to treat certain stomach/intestinal ulcers caused by a bacteria (H. pylori).

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
FDA Application #
ANDA205531
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2015
End Marketing Date
01-01-2016
Listing Expiration
01-01-2016
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 67457-697-10 identifies a specific commercial package of 1 pouch in 1 carton / 1 bag in 1 pouch / 100 ml in 1 bag of Metronidazole, labeled by Mylan Institutional Llc. 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 Mylan Institutional Llc on December 31, 2015. The current certification is valid through January 01, 2016.

What are the primary indications for this medication?

Metronidazole is an antibiotic that is used to treat a wide variety of infections. It works by stopping the growth of certain bacteria and parasites. This antibiotic treats only certain bacterial and parasitic infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Metronidazole may also be used with other medications to treat certain stomach/intestinal ulcers caused by a bacteria (H. pylori).

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457069710. 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)
67457-697-10
11-Digit CMS (5-4-2)
67457-0697-10

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