Metronidazole Vaginal Gel
NDC Package 45802-139-70

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

Package Information

Metronidazole Vaginal (metronidazole) gel is metronidazole is an antibiotic that is used to treat a wide variety of infections. This formulation utilizes a gel delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-139 and is authorized under FDA application ANDA211786.

Identification & Billing

NDC Package Code
45802-139-70
Package Description
1 TUBE in 1 CARTON / 70 g in 1 TUBE
Product Code
45802-139
11-Digit Billing Format
45802013970
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 Vaginal
Non-Proprietary Name
Metronidazole
Substance Name
Metronidazole
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
METRONIDAZOLE 7.5 mg/g
Pharmacologic Class
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA211786
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-08-2019
Listing Expiration
12-31-2026
Exclude Flag
N
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 45802-139-70 identifies a specific commercial package of 1 tube in 1 carton / 70 g in 1 tube of Metronidazole Vaginal, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This gel is formulated for vaginal use and contains metronidazole 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 Padagis Israel Pharmaceuticals Ltd on July 08, 2019. The current certification is valid through December 31, 2026.

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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802013970. 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)
45802-139-70
11-Digit CMS (5-4-2)
45802-0139-70

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