Stay Pure Acne Treatment
NDC Package 65447-377-00

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 inactivated by the FDA.

Stay Pure Acne Treatment is cleanse the skin thoroughly before applying the medicationCover the entire affected area with a thin layer one to three times daily or as directed by a health care professionalBecause excessive drying of the skin may occur, start with one application daily and then gradually increase to two or three times daily if needed. Marketed by Aloette, this product is identified by NDC 65447-377 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
65447-377-00
Package Description
1 TUBE in 1 CARTON / 15 mL in 1 TUBE
Product Code
65447-377
11-Digit Billing Format
65447037700
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Stay Pure Acne Treatment
Dosage Form
-
Usage Information
Cleanse the skin thoroughly before applying the medicationCover the entire affected area with a thin layer one to three times daily or as directed by a health care professionalBecause excessive drying of the skin may occur, start with one application daily and then gradually increase to two or three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.Keep carton for additional directions and warning information.

Regulatory & Marketing

Labeler Name
Aloette
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2015
Listing Expiration
12-31-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65447-377-00 identifies a specific commercial package of 1 tube in 1 carton / 15 ml in 1 tube of Stay Pure Acne Treatment, labeled by Aloette. 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 Aloette on January 01, 2015. The current certification is valid through December 31, 2020.

How is this Aloette product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65447037700. 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)
65447-377-00
11-Digit CMS (5-4-2)
65447-0377-00

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