Metronidazole
NDC Package 33261-786-01

11-digit billing NDC: 33261078601 · Billing unit: GM · 70 GM per package
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 is vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, - Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-786 and is authorized under FDA application NDA020208.

Identification & Billing

NDC Package Code
33261-786-01
Package Description
70 g in 1 TUBE, WITH APPLICATOR
Product Code
33261-786
11-Digit Billing Format
33261078601
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
70 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metronidazole
Dosage Form
-
Usage Information
Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, - Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
NDA020208
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
03-31-2007
Listing Expiration
12-31-2019
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 33261-786-01 identifies a specific commercial package of 70 g in 1 tube, with applicator of Metronidazole, labeled by Aidarex Pharmaceuticals Llc. This product is billed per "GM" gram and contains an estimated amount of 70 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 Aidarex Pharmaceuticals Llc on March 31, 2007. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261078601. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 70 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)
33261-786-01
11-Digit CMS (5-4-2)
33261-0786-01

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