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  4. NDC Product Code: 81542-202 Sulfacetamide Sodium, Sulfur

NDC 81542-202 Sulfacetamide Sodium, Sulfur

Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 81542-202?
  4. Sulfacetamide Sodium, Sulfur Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
81542-202
Proprietary Name:
Sulfacetamide Sodium, 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:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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]
    Bantry Pharma, Llc
    Labeler Code:
    81542
    Product Label ID:
    f433db67-d8a6-320e-e053-2995a90aab52
    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]
    02-08-2023
    End Marketing Date: [10]
    05-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 81542-202-12

    Package Description: 355 mL in 1 BOTTLE

    Product Details

    What is NDC 81542-202?

    The NDC code 81542-202 is assigned by the FDA to the product Sulfacetamide Sodium, Sulfur which is a human prescription drug product labeled by Bantry Pharma, Llc. The product's dosage form is solution and is administered via topical form. The product is distributed in a single package with assigned NDC code 81542-202-12 355 ml in 1 bottle . 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 Sulfacetamide Sodium, Sulfur?

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

    What are Sulfacetamide Sodium, 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/mL - An anti-bacterial agent that is used topically to treat skin infections and orally for urinary tract infections.
    • SULFUR 50 mg/mL - 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 Sulfacetamide Sodium, Sulfur UNII Codes?

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

    Which are Sulfacetamide Sodium, 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 Sulfacetamide Sodium, 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: 999613 - sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid Soap
    • RxCUI: 999613 - sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid Soap
    • RxCUI: 999613 - sulfacetamide sodium 10 % / sulfur 5 % Topical Cleanser

    Which are the Pharmacologic Classes for Sulfacetamide Sodium, 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".