Home NDC 44523-568-12 SULFACETAMIDE SODIUM
Product NDC 44523-568
Requested package NDC 44523-568-12
11-digit product format 445230568
Labeler code 44523
Product ID 44523-568_462c8be8-3914-a45d-e063-6394a90ac4c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULFACETAMIDE SODIUM
Dosage form LIQUID
Route TOPICAL
Labeler BioComp Pharma, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-09-15
Substance SULFACETAMIDE SODIUM
Active strength 100 mg/mL
Pharmacologic classes Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SULFACETAMIDE SODIUM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1006107 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44523-568-12 SULFACETAMIDE SODIUM 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 PEG-150 PENTAERYTHRITYL TETRASTEARATE INACTIVE INGREDIENT 8L4OOQ76AM SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATE INACTIVE INGREDIENT 395MHJ5PUR SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 PEG-6 CAPRYLIC/CAPRIC GLYCERIDES INACTIVE INGREDIENT GO50W2HWO8 SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-568 SULFACETAMIDE SODIUM LIQUID [BIOCOMP PHARMA, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20230829_f79c8287-a832-4f39-ad4d-3a12d64618ab.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44523-568-12 44523056812 355 mL in 1 BOTTLE, PLASTIC (44523-568-12) 355 ml 2011-09-15 0000-00-00 No No Current