Sulfacetamide Sodium

Product NDC
68071-5123
11-digit product format
680715123
Labeler code
68071
Product ID
68071-5123_1b54998d-88e0-357a-e063-6394a90a5948
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040066
Marketing category
ANDA
Marketing start
1994-12-28
Substance
SULFACETAMIDE SODIUM
Active strength
100 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
Sulfacetamide Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ
Rxcui1006120

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
68071-5123-5Sulfacetamide Sodium15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5123SULFACETAMIDE SODIUM SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240621_9910ec80-e37c-6a83-e053-2995a90a8237.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSN9910ec80-e37c-6a83-e053-2995a90a82373
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD9910ec80-e37c-6a83-e053-2995a90a82373
1006120sulfacetamide sodium 10 % Eye DropsSY9910ec80-e37c-6a83-e053-2995a90a82373
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSY9910ec80-e37c-6a83-e053-2995a90a82373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5123-56807151230515 mL in 1 BOTTLE, DROPPER (68071-5123-5) 15 ml2019-12-060000-00-00NoNoCurrent