SODIUM SULFACETAMIDE AND SULFUR

Product NDC
44523-748
11-digit product format
445230748
Labeler code
44523
Product ID
44523-748_36d7f15d-0115-a647-e063-6394a90ab97d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide 9.8% and Sulfur 4.8%
Dosage form
EMULSION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-12-17
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
98; 48 mg/g; mg/g
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
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g
SULFUR48 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1494169

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-748-10SODIUM SULFACETAMIDE AND SULFUR285 g in 1 BOTTLE, PLASTICEMULSION2852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-748-10GM - Gram44523-748d3e4dd2c-e020-425a-9ec1-8bd004a5592d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-748SODIUM SULFACETAMIDE AND SULFUR (SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8%) EMULSION [BIO COMP PHARMA, INC.]1Current NDC, 1 package rows20250108_1ba8bb47-6f7a-28ec-e063-6394a90a8eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494169sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated Liquid SoapPSN1ba8bb47-6f7a-28ec-e063-6394a90a8eb32
1494169sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Medicated Liquid SoapSCD1ba8bb47-6f7a-28ec-e063-6394a90a8eb32
1494169sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated Liquid SoapSY1ba8bb47-6f7a-28ec-e063-6394a90a8eb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44523-748-1044523074810285 g in 1 BOTTLE, PLASTIC (44523-748-10) 285 g2024-12-17NoNoCurrent