FDA.reportPublic FDA data

Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC
68071-1650
11-digit product format
680711650
Labeler code
68071
Product ID
68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA074449
Marketing category
ANDA
Marketing start
1995-12-29
Substance
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
Active strength
2.3; 100 mg/mL; mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 and Prednisolone Sodium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE2.3 mg/mL
SULFACETAMIDE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J, 4NRT660KJQ
Rxcui1012021

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1650-52023-04-06C16284748780-1ba0f9c33-57d2-a910-e053-dadaa90a0b85Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)
68071-1650-52023-01-30C16284748780-1ba0f9c33-57d2-a910-e053-dadaa90a0b85Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)
68071-1650-52021-02-11C16284748780-1ba0f9c33-57d2-a910-e053-dadaa90a0b85Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)
68071-1650-52021-01-29C16284748780-1ba0f9c33-57d2-a910-e053-dadaa90a0b85Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1650-5Sulfacetamide Sodium and Prednisolone Sodium Phosphate5 mL in 1 BOXSOLUTION/ DROPS54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1650SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240716_835def0b-ed5a-61a0-e053-2a91aa0ae7ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012021prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionPSN835def0b-ed5a-61a0-e053-2a91aa0ae7ae4
1012021prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD835def0b-ed5a-61a0-e053-2a91aa0ae7ae4
1012021prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionSY835def0b-ed5a-61a0-e053-2a91aa0ae7ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1650-5680711650055 mL in 1 BOX (68071-1650-5) 5 ml2019-03-050000-00-00NoNoCurrent