Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC
24208-317
11-digit product format
242080317
Labeler code
24208
Product ID
24208-317_06ea3d35-67bf-d0b8-e063-6294a90a5b0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incoporated
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-317-05Sulfacetamide Sodium and Prednisolone Sodium Phosphate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS59
24208-317-05Sulfacetamide Sodium and Prednisolone Sodium Phosphate1 in 1 CARTONSOLUTION/ DROPS19
24208-317-10Sulfacetamide Sodium and Prednisolone Sodium Phosphate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109
24208-317-10Sulfacetamide Sodium and Prednisolone Sodium Phosphate1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-317-05ML - Milliliter24208-3175a3ae041-d2aa-45a9-8daa-fc3b8c264d8912012-07-24
24208-317-10ML - Milliliter24208-3172ab3e583-4089-4a91-954b-a6d53d03689d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
THIMEROSALINACTIVE INGREDIENT2225PI3MOVSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-317SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BAUSCH & LOMB INCOPORATED]9Current NDC, Legacy NDC, 4 package rows20231005_9ec403eb-b5df-4e41-9e17-9d9d8ecac3f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012021prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionPSN9ec403eb-b5df-4e41-9e17-9d9d8ecac3f39
1012021prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD9ec403eb-b5df-4e41-9e17-9d9d8ecac3f39
1012021prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionSY9ec403eb-b5df-4e41-9e17-9d9d8ecac3f39
1012021prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionPSNf3e88cc8-90df-4119-8c81-4c92f3cef5aa5
1012021prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDf3e88cc8-90df-4119-8c81-4c92f3cef5aa5
1012021prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionSYf3e88cc8-90df-4119-8c81-4c92f3cef5aa5
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-317-05242080317051 BOTTLE, DROPPER in 1 CARTON (24208-317-05) / 5 mL in 1 BOTTLE, DROPPER1995-12-290000-00-00NoNoCurrent
24208-317-10242080317101 BOTTLE, DROPPER in 1 CARTON (24208-317-10) / 10 mL in 1 BOTTLE, DROPPER1995-12-290000-00-00NoNoCurrent