Vandazole Gel
NDC Package 0245-0860-70

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

Package Information

Vandazole (metronidazole) gel is a medication used to treat certain types of bacterial infections in the vagina. This formulation utilizes a gel delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 0245-0860 and is authorized under FDA application NDA021806.

Identification & Billing

NDC Package Code
0245-0860-70
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 70 g in 1 TUBE, WITH APPLICATOR
Product Code
0245-0860
11-Digit Billing Format
00245086070
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
Vandazole
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
This medication is used to treat certain types of bacterial infections in the vagina. Metronidazole is an antibiotic that works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021806
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-04-2005
End Marketing Date
05-31-2027
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 0245-0860-70 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 70 g in 1 tube, with applicator of Vandazole, a human prescription drug labeled by Upsher-smith Laboratories, Llc. 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 Upsher-smith Laboratories, Llc on October 04, 2005.

What are the primary indications for this medication?

This medication is used to treat certain types of bacterial infections in the vagina. Metronidazole is an antibiotic that works by stopping the growth of bacteria.

How is this Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00245086070. 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 (4-4-2)
0245-0860-70
11-Digit CMS (5-4-2)
00245-0860-70

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