Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC
53002-8690
Requested package NDC
53002-8690-2
11-digit product format
530028690
Labeler code
53002
Product ID
53002-8690_cb1c01d1-f185-4005-9390-6797b9d42e31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074449
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE
Active strength
100 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-869053002-8690-2IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8690-1Sulfacetamide Sodium and Prednisolone Sodium Phosphate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS55
53002-8690-2Sulfacetamide Sodium and Prednisolone Sodium Phosphate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8690SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_f3e88cc8-90df-4119-8c81-4c92f3cef5aa.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8690-25300286900210 mL in 1 BOTTLE, DROPPER (53002-8690-2) 10 ml2018-10-010000-00-00NoNoCurrent