Noritate Cream
NDC Package 0187-5202-35

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

Package Information

Noritate (metronidazole) cream is a medication used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. This formulation utilizes a cream delivery system. Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-5202 and is authorized under FDA application NDA020743.

Identification & Billing

NDC Package Code
0187-5202-35
Package Description
3.5 g in 1 TUBE
Product Code
0187-5202
11-Digit Billing Format
00187520235
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Noritate
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
This medication is used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It may help to decrease redness, swelling and the number of pimples caused by rosacea. This medication is an antibiotic. For the treatment of rosacea, metronidazole is believed to work by decreasing swelling (inflammation). Some brands of this medication also contain sunscreens (see also Notes section).

Regulatory & Marketing

Labeler Name
Bausch Health Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020743
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-09-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0187-5202). Click a package code to view its specific billing and regulatory data.

0187-5202-60
1 TUBE in 1 CARTON / 60 g in 1 TUBE

* 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 0187-5202-35 identifies a specific commercial package of 3.5 g in 1 tube of Noritate, a human prescription drug labeled by Bausch Health Us, Llc. 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 Bausch Health Us, Llc on August 09, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It may help to decrease redness, swelling and the number of pimples caused by rosacea. This medication is an antibiotic. For the treatment of rosacea, metronidazole is believed to work by decreasing swelling (inflammation). Some brands of this medication also contain sunscreens (see also Notes section).

How is this Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187520235. 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)
0187-5202-35
11-Digit CMS (5-4-2)
00187-5202-35

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