Rhofade
NDC Package 71180-003-65

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Rhofade is a medication used to treat a certain skin disorder known as rosacea. Marketed by Aclaris Therapeutics, Inc., this product is identified by NDC 71180-003 and is authorized under FDA application NDA208552.

Identification & Billing

NDC Package Code
71180-003-65
Package Description
1 BOTTLE, PUMP in 1 CARTON / 60 g in 1 BOTTLE, PUMP
Product Code
71180-003
11-Digit Billing Format
71180000365
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rhofade
Dosage Form
-
Usage Information
This medication is used to treat a certain skin disorder known as rosacea. It works by narrowing the blood vessels in the face. Oxymetazoline belongs to a class of drugs known as a sympathomimetic (alpha receptor agonist). It may help to decrease facial redness caused by rosacea.

Regulatory & Marketing

Labeler Name
Aclaris Therapeutics, Inc.
FDA Application #
NDA208552
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-18-2017
Listing Expiration
12-31-2021
Exclude Flag
I
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 (71180-003). Click a package code to view its specific billing and regulatory data.

71180-003-15
3 g in 1 TUBE
71180-003-30
1 TUBE in 1 CARTON / 30 g in 1 TUBE
71180-003-35
1 BOTTLE, PUMP in 1 CARTON / 30 g in 1 BOTTLE, PUMP
71180-003-45
1 TUBE in 1 CARTON / 45 g in 1 TUBE
71180-003-60
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 71180-003-65 identifies a specific commercial package of 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump of Rhofade, labeled by Aclaris Therapeutics, Inc.. 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 Aclaris Therapeutics, Inc. on January 18, 2017. The current certification is valid through December 31, 2021.

What are the primary indications for this medication?

This medication is used to treat a certain skin disorder known as rosacea. It works by narrowing the blood vessels in the face. Oxymetazoline belongs to a class of drugs known as a sympathomimetic (alpha receptor agonist). It may help to decrease facial redness caused by rosacea.

How is this Aclaris Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71180000365. 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)
71180-003-65
11-Digit CMS (5-4-2)
71180-0003-65

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