Sulfacetamide Sodium

Product NDC
0574-4190
11-digit product format
005744190
Labeler code
0574
Product ID
0574-4190_b50202dd-c913-4ae7-afbb-74be0db2ef80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA080029
Marketing category
ANDA
Marketing start
2014-08-13
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4190-35GM - Gram0574-4190288cc548-3196-44ae-b718-7c52458a7f3212014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4190SULFACETAMIDE SODIUM OINTMENT [PADAGIS US LLC]4Legacy NDC20241109_558280c6-893e-4645-9018-40c69be936d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4190-35005744190351 TUBE in 1 CARTON (0574-4190-35) > 3.5 g in 1 TUBE1 tube2014-08-130000-00-00NoNoCurrent