Klaron Lotion
NDC Package 0187-5198-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Klaron (sulfacetamide sodium) lotions is a medication used to treat acne. This formulation utilizes a lotion delivery system. Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-5198 and is authorized under FDA application NDA019931.

Identification & Billing

NDC Package Code
0187-5198-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
0187-5198
11-Digit Billing Format
00187519804
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Klaron
Non-Proprietary Name
Sulfacetamide Sodium
Substance Name
Sulfacetamide Sodium
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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)
SULFACETAMIDE SODIUM 100 mg/mL
Pharmacologic Class
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
Bausch Health Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019931
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-1996
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0187-5198-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Klaron, a human prescription drug labeled by Bausch Health Us, Llc. This lotion is formulated for topical use and contains sulfacetamide sodium 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 Bausch Health Us, Llc on December 23, 1996. The current certification is valid through December 31, 2026.

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 Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187519804. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0187-5198-04
11-Digit CMS (5-4-2)
00187-5198-04

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