Sulfacetamide Sodium

Product NDC
53002-9010
11-digit product format
530029010
Labeler code
53002
Product ID
53002-9010_9732fc28-a4c2-445a-952f-cd5a7d792b5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040066
Marketing category
ANDA
Marketing start
1994-12-28
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
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 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9010-3Sulfacetamide Sodium15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9010SULFACETAMIDE SODIUM SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_d3709517-7eec-44cf-be71-2ce1ac9f0871.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSNd3709517-7eec-44cf-be71-2ce1ac9f08715
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDd3709517-7eec-44cf-be71-2ce1ac9f08715
1006120sulfacetamide sodium 10 % Eye DropsSYd3709517-7eec-44cf-be71-2ce1ac9f08715
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSYd3709517-7eec-44cf-be71-2ce1ac9f08715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9010-35300290100315 mL in 1 BOTTLE, DROPPER (53002-9010-3) 15 ml2021-05-010000-00-00NoNoCurrent