Klaron
NDC Package 0066-7500-04

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 discontinued by the firm.

Klaron is a medication used to treat acne. Marketed by Dermik Laboratories, this product is identified by NDC 0066-7500 and is authorized under FDA application NDA019931.

Identification & Billing

NDC Package Code
0066-7500-04
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
0066-7500
11-Digit Billing Format
00066750004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML

Clinical Specifications

Proprietary Name
Klaron
Dosage Form
-
Usage Information
This medication is used to treat acne. It works by stopping the growth of certain bacteria on the skin that can worsen acne. Sodium sulfacetamide belongs to a class of drugs known as sulfa antibiotics.

Regulatory & Marketing

Labeler Name
Dermik Laboratories
FDA Application #
NDA019931
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-1996
End Marketing Date
01-01-2014
Listing Expiration
01-01-2014
Exclude Flag
D
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 0066-7500-04 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Klaron, labeled by Dermik Laboratories. 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 Dermik Laboratories on December 23, 1996. The current certification is valid through January 01, 2014.

What are the primary indications for this medication?

This medication is used to treat acne. It works by stopping the growth of certain bacteria on the skin that can worsen acne. Sodium sulfacetamide belongs to a class of drugs known as sulfa antibiotics.

How is this Dermik Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00066750004. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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 (4-4-2)
0066-7500-04
11-Digit CMS (5-4-2)
00066-7500-04

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