Mirvaso Gel
NDC Package 0299-5980-35

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

Mirvaso (brimonidine tartrate) gel is a medication used to treat a certain skin disorder called rosacea. This formulation utilizes a gel delivery system. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-5980 and is authorized under FDA application NDA204708.

Identification & Billing

NDC Package Code
0299-5980-35
Package Description
1 BOTTLE, PUMP in 1 CARTON / 30 g in 1 BOTTLE, PUMP
Product Code
0299-5980
11-Digit Billing Format
00299598035
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mirvaso
Non-Proprietary Name
Brimonidine Tartrate
Substance Name
Brimonidine Tartrate
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
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)
BRIMONIDINE TARTRATE 5 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat a certain skin disorder called rosacea. It works by narrowing blood vessels to reduce redness. Brimonidine belongs to a class of drugs known as alpha agonists.

Regulatory & Marketing

Labeler Name
Galderma Laboratories, L.p.
Product Type
Human Prescription Drug
FDA Application #
NDA204708
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-23-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0299-5980). Click a package code to view its specific billing and regulatory data.

0299-5980-00
1 TUBE in 1 BLISTER PACK / 2 g in 1 TUBE
0299-5980-02
2 g in 1 TUBE
0299-5980-30
30 g in 1 TUBE
0299-5980-45
45 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 0299-5980-35 identifies a specific commercial package of 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump of Mirvaso, a human prescription drug labeled by Galderma Laboratories, L.p.. This gel is formulated for topical use and contains brimonidine tartrate 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 Galderma Laboratories, L.p. on August 23, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain skin disorder called rosacea. It works by narrowing blood vessels to reduce redness. Brimonidine belongs to a class of drugs known as alpha agonists.

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: 00299598035. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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)
0299-5980-35
11-Digit CMS (5-4-2)
00299-5980-35

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