Oc Eight
NDC Package 42485-003-01

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.

Oc Eight is cleanse the skin thoroughly before applyingcover the entire affected area with a thin layer 1 to 3 times a daybecause excessive drying of th skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other dayif going outside, apply a sunscreen after using this product.  Allow OC Eight Acne Mattifying Gel to dry, then follow directions in the sunscreen labeling.  If irritation or sensitivity develops, stop use of both products and ask a doctor. Marketed by Biopelle, Inc., this product is identified by NDC 42485-003 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
42485-003-01
Package Description
45 g in 1 TUBE
Product Code
42485-003
11-Digit Billing Format
42485000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oc Eight
Dosage Form
-
Usage Information
Cleanse the skin thoroughly before applyingcover the entire affected area with a thin layer 1 to 3 times a daybecause excessive drying of th skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other dayif going outside, apply a sunscreen after using this product.  Allow OC Eight Acne Mattifying Gel to dry, then follow directions in the sunscreen labeling.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Regulatory & Marketing

Labeler Name
Biopelle, Inc.
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
04-01-2011
Listing Expiration
12-31-2017
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 42485-003-01 identifies a specific commercial package of 45 g in 1 tube of Oc Eight, labeled by Biopelle, 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 Biopelle, Inc. on April 01, 2011. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42485000301. 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)
42485-003-01
11-Digit CMS (5-4-2)
42485-0003-01

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