Sodium Sulfacetamide And Sulfur Lotion
NDC 44523-605
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Sodium Sulfacetamide And Sulfur (sodium sulfacetamide, sulfur) is a UNAPPROVED DRUG OTHER-approved product labeled by Biocomp Pharma, Inc.. This medication is typically used as a sulfonamide antibacterial [epc]. It is supplied as a yellow lotion for topical administration. This product entry covers the primary NDC 44523-605 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
44523-605
Proprietary Name:
Sodium Sulfacetamide And Sulfur
Non-Proprietary Name: [1]
Sodium Sulfacetamide, Sulfur
Substance Name: [2]
Sulfacetamide Sodium; Sulfur
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Lotion
- An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
44523
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
04-15-2011
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Product Characteristics
Color(s):
YELLOW (C48330 - LIGHT YELLOW)
Code Structure Chart
Product Details
What is NDC 44523-605?
The NDC code 44523-605 is assigned by the FDA to the product Sodium Sulfacetamide And Sulfur. It is commonly known by its generic name, sodium sulfacetamide, sulfur. This pharmaceutical product is labeled by Biocomp Pharma, Inc. and is currently categorized as listed product. The medication is a lotion administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 44523-605-16. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
What are Active Ingredients of this product?
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 90 mg/g - An anti-bacterial agent that is used topically to treat skin infections and orally for urinary tract infections.
- SULFUR 45 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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SULFUR (UNII: 70FD1KFU70)
- SULFUR (UNII: 70FD1KFU70) (Active Moiety)
- SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ)
- SULFACETAMIDE (UNII: 4965G3J0F5) (Active Moiety)
Which are the Pharmacologic Classes of this product?
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.
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".
