1. Home
  2. Labeler Index
  3. Biocomp Pharma, Inc.
  4. NDC Product Code: 44523-535 Sodium Sulfacetamide, Sulfur

NDC 44523-535 Sodium Sulfacetamide, Sulfur

Sulfacetamide Sodium,Sulfur Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 44523-535?
  5. Sodium Sulfacetamide, Sulfur Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Get all the details for National Drug Code (NDC) 44523-535 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
44523-535
Proprietary Name:
Sodium Sulfacetamide, Sulfur
Non-Proprietary Name: [1]
Sulfacetamide Sodium, Sulfur
Substance Name: [2]
Sulfacetamide Sodium; Sulfur
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Labeler Name: [5]
Biocomp Pharma, Inc.
Labeler Code:
44523
Product Label ID:
01db0daf-1704-47c9-8845-6d5ec56e33ec
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
09-15-2011
End Marketing Date: [10]
10-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW)

Code Structure Chart

Product Details

What is NDC 44523-535?

The NDC code 44523-535 is assigned by the FDA to the product Sodium Sulfacetamide, Sulfur which is a human prescription drug product labeled by Biocomp Pharma, Inc.. The generic name of Sodium Sulfacetamide, Sulfur is sulfacetamide sodium, sulfur. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 44523-535-02 57 g in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Sodium Sulfacetamide, Sulfur?

This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

What are Sodium Sulfacetamide, Sulfur Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SULFACETAMIDE SODIUM 100 mg/g - An anti-bacterial agent that is used topically to treat skin infections and orally for urinary tract infections.
  • SULFUR 20 mg/g - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.

Which are Sodium Sulfacetamide, Sulfur UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Sodium Sulfacetamide, Sulfur Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Sodium Sulfacetamide, Sulfur?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1000731 - sulfacetamide sodium 10 % / sulfur 2 % Topical Cream
  • RxCUI: 1000731 - sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Topical Cream

Which are the Pharmacologic Classes for Sodium Sulfacetamide, Sulfur?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".