Kleer-plex Advanced Acne Care System
NDC Package 37945-876-91

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.

Kleer-plex Advanced Acne Care System is acne Treatment WashAt least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth.Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes.Repeat after perspiration or makeup use.If dryness occurs, reduce frequency to once each day.Acne Treatment GelEach night, dispense a small amount of gel onto the fingertips.Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.Repeat after perspiration or makeup use.If dryness occurs, reduce frequency to once each day. Marketed by Bio-medical & Pharmaceutical Manufacturing Corporation, this product is identified by NDC 37945-876 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
37945-876-91
Package Description
1 KIT in 1 KIT * 236.558 mL in 1 BOTTLE * 1 BOTTLE in 1 BOX (37945-874-11) / 30 mL in 1 BOTTLE * 1 APPLICATOR in 1 BOX (37945-894-05) / 15 mL in 1 APPLICATOR * 1 BOTTLE, PUMP in 1 BOX (37945-870-40) / 118 mL in 1 BOTTLE, PUMP
Product Code
37945-876
11-Digit Billing Format
37945087691
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kleer-plex Advanced Acne Care System
Dosage Form
-
Usage Information
Acne Treatment WashAt least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth.Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes.Repeat after perspiration or makeup use.If dryness occurs, reduce frequency to once each day.Acne Treatment GelEach night, dispense a small amount of gel onto the fingertips.Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.Repeat after perspiration or makeup use.If dryness occurs, reduce frequency to once each day.

Regulatory & Marketing

Labeler Name
Bio-medical & Pharmaceutical Manufacturing Corporation
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
11-03-2014
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 37945-876-91 identifies a specific commercial package of 1 kit in 1 kit * 236.558 ml in 1 bottle * 1 bottle in 1 box (37945-874-11) / 30 ml in 1 bottle * 1 applicator in 1 box (37945-894-05) / 15 ml in 1 applicator * 1 bottle, pump in 1 box (37945-870-40) / 118 ml in 1 bottle, pump of Kleer-plex Advanced Acne Care System, labeled by Bio-medical & Pharmaceutical Manufacturing Corporation. 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 Bio-medical & Pharmaceutical Manufacturing Corporation on November 03, 2014. The current certification is valid through December 31, 2017.

How is this Bio-medical & Pharmaceutical Manufacturing Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 37945087691. 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)
37945-876-91
11-Digit CMS (5-4-2)
37945-0876-91

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