Metrogel
NDC Package 0299-3835-45

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Metrogel is a medication used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-3835 and is authorized under FDA application NDA019737.

Identification & Billing

NDC Package Code
0299-3835-45
Package Description
45 g in 1 TUBE
Product Code
0299-3835
11-Digit Billing Format
00299383545

Clinical Specifications

Proprietary Name
Metrogel
Dosage Form
-
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
Galderma Laboratories, L.p.
FDA Application #
NDA019737
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-22-1988
End Marketing Date
09-30-2010
Listing Expiration
09-30-2010
Exclude Flag
D
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 0299-3835-45 identifies a specific commercial package of 45 g in 1 tube of Metrogel, labeled by Galderma Laboratories, L.p.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Galderma Laboratories, L.p. on November 22, 1988. The current certification is valid through September 30, 2010.

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 Galderma Laboratories, L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00299383545. 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)
0299-3835-45
11-Digit CMS (5-4-2)
00299-3835-45

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