FDA.reportPublic FDA data

Sodium Sulfacetamide 8% and Sulfur 4%

Product NDC
71399-0487
11-digit product format
713990487
Labeler code
71399
Product ID
71399-0487_a4bb29b0-065f-428b-9d9b-bb4e564449d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Akron Pharma Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
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 8% and Sulfur 4%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM80 mg/mL
SULFUR40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1010234

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
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0487-6Sodium Sulfacetamide 8% and Sulfur 4%473 mL in 1 BOTTLE, PLASTICSUSPENSION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0487-6ML - Milliliter71399-0487797a0cc6-af1c-4dc1-a17f-a9c736f73bbd12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0487SODIUM SULFACETAMIDE 8% AND SULFUR 4% (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [AKRON PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20240926_bfbe625c-5679-4363-913a-2ab03198f4f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNbfbe625c-5679-4363-913a-2ab03198f4f04
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDbfbe625c-5679-4363-913a-2ab03198f4f04
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYbfbe625c-5679-4363-913a-2ab03198f4f04
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYbfbe625c-5679-4363-913a-2ab03198f4f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0487-671399048706473 mL in 1 BOTTLE, PLASTIC (71399-0487-6) 473 ml2024-09-130000-00-00NoNoCurrent