Metronidazole Gel
NDC Package 68682-455-70

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

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 Oceanside Pharmaceuticals, this product is identified by NDC 68682-455 and is authorized under FDA application NDA020208.

Identification & Billing

NDC Package Code
68682-455-70
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 70 g in 1 TUBE, WITH APPLICATOR
Product Code
68682-455
11-Digit Billing Format
68682045570
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
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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
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
04-01-2015
End Marketing Date
07-31-2026
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 68682-455-70 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 70 g in 1 tube, with applicator of Metronidazole, a human prescription drug labeled by Oceanside Pharmaceuticals. 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 Oceanside Pharmaceuticals on April 01, 2015.

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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682045570. 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)
68682-455-70
11-Digit CMS (5-4-2)
68682-0455-70

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