Rhofade Cream
NDC Package 71403-003-30

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

Rhofade (oxymetazoline hydrochloride) cream is a medication used to treat a certain skin disorder known as rosacea. This formulation utilizes a cream delivery system. Marketed by Epi Health, Llc, this product is identified by NDC 71403-003 and is authorized under FDA application NDA208552.

Identification & Billing

NDC Package Code
71403-003-30
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
71403-003
11-Digit Billing Format
71403000330
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
Rhofade
Non-Proprietary Name
Oxymetazoline Hydrochloride
Substance Name
Oxymetazoline Hydrochloride
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)
OXYMETAZOLINE HYDROCHLORIDE 1 g/100g
Pharmacologic Class
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
Epi Health, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208552
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-18-2021
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 (71403-003). Click a package code to view its specific billing and regulatory data.

71403-003-15
1 TUBE in 1 CARTON / 3 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 71403-003-30 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Rhofade, a human prescription drug labeled by Epi Health, Llc. This cream is formulated for topical use and contains oxymetazoline hydrochloride 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 Epi Health, Llc on January 18, 2021. 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 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 Epi Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71403000330. 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 (5-3-2)
71403-003-30
11-Digit CMS (5-4-2)
71403-0003-30

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