FDA.reportPublic FDA data

SULFACETAMIDE SODIUM, SULFUR

Product NDC
24470-934
11-digit product format
244700934
Labeler code
24470
Product ID
24470-934_0fa2c52d-5d4b-4b83-e063-6394a90a5406
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LOTION
Route
TOPICAL
Labeler
Cintex Services, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-23
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 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
SULFACETAMIDE SODIUM, SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1005856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
24470-934-01SULFACETAMIDE SODIUM, SULFUR30 g in 1 BOTTLE, PLASTICLOTION301
24470-934-01SULFACETAMIDE SODIUM, SULFUR1 in 1 CARTONLOTION11
24470-934-02SULFACETAMIDE SODIUM, SULFUR60 g in 1 BOTTLE, PLASTICLOTION601
24470-934-02SULFACETAMIDE SODIUM, SULFUR1 in 1 CARTONLOTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-934-01GM - Gram24470-9342ccbef3e-e01c-4b39-8b7e-a59c5950c6cb12024-03-12
24470-934-02GM - Gram24470-9346312a578-3826-48a0-ab76-d5dcb5296c4712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-934SULFACETAMIDE SODIUM, SULFUR LOTION [CINTEX SERVICES, LLC]1Current NDC, 4 package rows20240124_0fa2c52d-5d4a-4b83-e063-6394a90a5406.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical LotionPSN0fa2c52d-5d4a-4b83-e063-6394a90a54061
1005856sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical LotionSCD0fa2c52d-5d4a-4b83-e063-6394a90a54061
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical LotionSY0fa2c52d-5d4a-4b83-e063-6394a90a54061
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical SuspensionSY0fa2c52d-5d4a-4b83-e063-6394a90a54061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24470-934-01244700934011 BOTTLE, PLASTIC in 1 CARTON (24470-934-01) / 30 g in 1 BOTTLE, PLASTIC2024-01-23NoNoCurrent
24470-934-02244700934021 BOTTLE, PLASTIC in 1 CARTON (24470-934-02) / 60 g in 1 BOTTLE, PLASTIC2024-01-23NoNoCurrent