42192-113 NDC - SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS (SODIUM SULFACETAMIDE, SULFUR)

Drug Information

Product NDC: 42192-113

Proprietary Name: SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS

Non Proprietary Name: SODIUM SULFACETAMIDE, SULFUR

Active Ingredient(s):
  • 10 g/100g SULFACETAMIDE SODIUM;
  • 4 g/100g SULFUR


Administration Route(s): TOPICAL

Dosage Form(s): SWAB

Pharmacy Class(es):
  • Sulfonamide Antibacterial [EPC];
  • Sulfonamides [CS]

Labeler Information

Labeler Name: Acella Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:7/30/2009

Package Information

No. Package Code Package Description Billing Unit
142192-113-6060 POUCH in 1 BOX (42192-113-60) / 3.7 g in 1 POUCHEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC42192-113The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMESODIUM SULFACETAMIDE - SULFUR CLEANSING PADSThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESODIUM SULFACETAMIDE, SULFURThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESWABThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/30/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEAcella Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESULFACETAMIDE SODIUM; SULFURAn 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.
ACTIVE NUMERATOR STRENGTH10; 4 
ACTIVE INGRED UNITg/100g; g/100g 
PHARM CLASSESSulfonamide Antibacterial [EPC], Sulfonamides [CS] 

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This page was last updated on: 2/1/2023