Metronidazole Cream
NDC Package 68682-202-60

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

Package Information

Metronidazole cream is metronidazole is an antibiotic that is used to treat a wide variety of infections. This formulation utilizes a cream delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-202 and is authorized under FDA application NDA020743.

Identification & Billing

NDC Package Code
68682-202-60
Package Description
60 g in 1 TUBE
Product Code
68682-202
11-Digit Billing Format
68682020260
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metronidazole
Non-Proprietary Name
Metronidazole
Substance Name
Metronidazole
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
METRONIDAZOLE 10 mg/60g
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 #
NDA020743
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2023
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 68682-202-60 identifies a specific commercial package of 60 g in 1 tube of Metronidazole, a human prescription drug labeled by Oceanside Pharmaceuticals. This cream is formulated for topical 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 August 01, 2023. 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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682020260. 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)
68682-202-60
11-Digit CMS (5-4-2)
68682-0202-60

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