Avene Xeracalm Eczema Calming Relief Balm Cream
NDC Package 64760-777-01

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

Avene Xeracalm Eczema Calming Relief Balm (colloidal oatmeal) cream is apply as needed. This formulation utilizes a cream delivery system. Marketed by Pierre Fabre Usa Inc., this product is identified by NDC 64760-777 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
64760-777-01
Package Description
100 g in 1 TUBE
Product Code
64760-777
11-Digit Billing Format
64760077701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Avene Xeracalm Eczema Calming Relief Balm
Non-Proprietary Name
Colloidal Oatmeal
Substance Name
Oatmeal
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)
OATMEAL 1 g/100g
Pharmacologic Class
Usage Information
Apply as needed. For targeted areas on body, face and hands.

Regulatory & Marketing

Labeler Name
Pierre Fabre Usa Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2024
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 (64760-777). Click a package code to view its specific billing and regulatory data.

64760-777-02
1 TUBE in 1 BOX / 5 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 64760-777-01 identifies a specific commercial package of 100 g in 1 tube of Avene Xeracalm Eczema Calming Relief Balm, a human over the counter drug labeled by Pierre Fabre Usa Inc.. This cream is formulated for topical use and contains oatmeal 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 Pierre Fabre Usa Inc. on May 01, 2024. The current certification is valid through December 31, 2026.

How is this Pierre Fabre Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64760077701. 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)
64760-777-01
11-Digit CMS (5-4-2)
64760-0777-01

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