Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC
24208-317
Requested package NDC
24208-317-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUMEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-293f01610625f2…
2019-09-15 20:21 UTC2019-09A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29cb3db0bc1861…

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
SULFACETAMIDE SODIUM2.3 mg/mL
PREDNISOLONE SODIUM PHOSPHATE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup
IV021NXA9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012021Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ec403eb-b5df-4e41-9e17-9d9d8ecac3f3Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfacetamide Sodium and Prednisolone Sodium PhosphateSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATENuCare Pharmaceuticals,Inc.835def0b-ed5a-61a0-e053-2a91aa0ae7ae2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074449
application number: ANDA074449
Sulfacetamide Sodium and Prednisolone Sodium PhosphateSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEBausch & Lomb Incoporated9ec403eb-b5df-4e41-9e17-9d9d8ecac3f32023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074449
application number: ANDA074449
ndc (package): 24208-317-10
ndc (product): 24208-317
ndc11 (package): 24208031710

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
24208-317-10242080317101 BOTTLE, DROPPER in 1 CARTON (24208-317-10) / 10 mL in 1 BOTTLE, DROPPER1995-12-290000-00-00NoNoCurrent