FDA.reportPublic FDA data

Sulfacetamide Sodium

Product NDC
50090-0246
11-digit product format
500900246
Labeler code
50090
Product ID
50090-0246_bb2c58d1-34b4-4100-9a89-a9bf4b0a0b59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfacetamide Sodium
Listing expiration
2027-12-31

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0246-02023-02-07C16284748780-1f386c64a-1adf-0266-e053-dadaa90a7c1aSulfacetamide Sodium Ophthalmic Solution, USP
50090-0246-02023-01-30C16284748780-1f386c64a-1adf-0266-e053-dadaa90a7c1aSulfacetamide Sodium Ophthalmic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0246-0Sulfacetamide Sodium15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1514
50090-0246-0Sulfacetamide Sodium1 in 1 CARTONSOLUTION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0246-0ML - Milliliter50090-02463debce5c-2535-4c00-a806-95bec9622eed12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0246SULFACETAMIDE SODIUM SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20230208_f212af23-be3d-4e82-9f6f-5ddce12a89da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSNf212af23-be3d-4e82-9f6f-5ddce12a89da14
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDf212af23-be3d-4e82-9f6f-5ddce12a89da14
1006120sulfacetamide sodium 10 % Eye DropsSYf212af23-be3d-4e82-9f6f-5ddce12a89da14
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSYf212af23-be3d-4e82-9f6f-5ddce12a89da14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0246-0500900246001 BOTTLE, DROPPER in 1 CARTON (50090-0246-0) / 15 mL in 1 BOTTLE, DROPPER2016-06-290000-00-00NoNoCurrent