Sulfacetamide Sodium Lotion
NDC Package 45802-896-26

11-digit billing NDC: 45802089626 · Billing unit: ML · 118 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sulfacetamide Sodium lotions is sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris. This formulation utilizes a lotion delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-896 and is authorized under FDA application ANDA078649.

Identification & Billing

NDC Package Code
45802-896-26
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
45802-896
11-Digit Billing Format
45802089626
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sulfacetamide Sodium
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
Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA078649
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-17-2012
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 45802-896-26 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Sulfacetamide Sodium, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. 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 Padagis Israel Pharmaceuticals Ltd on October 17, 2012. The current certification is valid through December 31, 2026.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802089626. 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 (5-3-2)
45802-896-26
11-Digit CMS (5-4-2)
45802-0896-26

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