Home NDC 44523-624-16 SODIUM SULFACETAMIDE AND SULFUR
Product NDC 44523-624
Requested package NDC 44523-624-16
11-digit product format 445230624
Labeler code 44523
Product ID 44523-624_36d7ebf4-3712-9d8b-e063-6394a90ae579
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULFACETAMIDE SODIUM, SULFUR
Dosage form SUSPENSION
Route TOPICAL
Labeler BioComp Pharma, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-01-27
Substance SULFACETAMIDE SODIUM; SULFUR
Active strength 80; 40 mg/mL; 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 SODIUM SULFACETAMIDE AND SULFUR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 80 mg/mL SULFUR 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup 70FD1KFU70 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010234 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 44523-624-16 SODIUM SULFACETAMIDE AND SULFUR 473 mL in 1 BOTTLE SUSPENSION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-624 SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIO COMP PHARMA, INC.] 1 Current NDC, 1 package rows 20250129_1ba8e7a0-d700-c96b-e063-6394a90a0463.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 Sample Exclude flag Status 44523-624-16 44523062416 473 mL in 1 BOTTLE (44523-624-16) 473 ml 2025-01-27 No No Current