FDA.reportPublic FDA data

sulfacetamide sodium and sulfur

Product NDC
28595-501
11-digit product format
285950501
Labeler code
28595
Product ID
28595-501_4a912755-c660-18d3-e063-6294a90a1a38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium and sulfur
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Allegis Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-18
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
90; 42.5 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sulfacetamide sodium and sulfur
Brand name suffix
Sodium Sulfacetamide - Sulfur
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM90 mg/mL
SULFUR42.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui2531383

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
28595-501-08sulfacetamide sodium and sulfurSodium Sulfacetamide - Sulfur237 mL in 1 BOTTLESUSPENSION2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-501-08ML - Milliliter28595-50119074eca-2228-4c5b-84ac-a2c3012e1f4312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-501SULFACETAMIDE SODIUM AND SULFUR SODIUM SULFACETAMIDE - SULFUR (SULFACETAMIDE SODIUM AND SULFUR) SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240619_1aa1025f-c568-34d3-e063-6394a90a37b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2531383sulfacetamide sodium 9 % / sulfur 4.25 % Medicated Liquid SoapPSN1aa1025f-c568-34d3-e063-6394a90a37b83
2531383sulfacetamide sodium 90 MG/ML / sulfur 42.5 MG/ML Medicated Liquid SoapSCD1aa1025f-c568-34d3-e063-6394a90a37b83
2531383sulfacetamide sodium 9 % / sulfur 4.25 % Medicated Liquid SoapSY1aa1025f-c568-34d3-e063-6394a90a37b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
28595-501-0828595050108237 mL in 1 BOTTLE (28595-501-08) 237 ml2024-06-18NoNoCurrent