Sulfacetamide Sodium

Product NDC
53002-9010
11-digit product format
530029010
Labeler code
53002
Product ID
53002-9010_9732fc28-a4c2-445a-952f-cd5a7d792b5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040066
Marketing category
ANDA
Marketing start
1994-12-28
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-9010IInactivated by FDA2026-08-17
excluded packagepackage53002-901053002-9010-3IInactivated by FDA2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-9010-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-9010-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-9010-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-9010-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-9010-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-9010-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-9010-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-9010-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-9010-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040066-001SULFACETAMIDE SODIUMSULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040066-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICATRS1994-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-283f01610625f2…
2019-09-15 20:21 UTC2019-09A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040066-001SULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICAT1994-12-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040066-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040066-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040066-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040066-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040066-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040066-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040066-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040066-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040066-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040066-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040066-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040066-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040066-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040066-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040066-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040066-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040066-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040066-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040066-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040066-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040066-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040066-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040066-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040066-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040066-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040066-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040066-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040066-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040066-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040066-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040066-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040066-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040066-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040066-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040066-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040066-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040066-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040066-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040066-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040066-001AT1e64feba35796…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9010-3Sulfacetamide Sodium15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9010SULFACETAMIDE SODIUM SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_d3709517-7eec-44cf-be71-2ce1ac9f0871.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfacetamide SodiumSULFACETAMIDE SODIUMA-S Medication Solutionsf212af23-be3d-4e82-9f6f-5ddce12a89da2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040066
application number: ANDA040066
Sulfacetamide SodiumSULFACETAMIDE SODIUMPreferred Pharmaceuticals, Inccf0cc763-49b5-435d-852b-e7617c8d32862025-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040066
application number: ANDA040066
Sulfacetamide SodiumSULFACETAMIDE SODIUMNuCare Pharmaceuticals,Inc.9910ec80-e37c-6a83-e053-2995a90a82372024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040066
application number: ANDA040066
Sulfacetamide SodiumSULFACETAMIDE SODIUMBausch & Lomb Incorporated6c1b2658-e756-4f31-9bc8-f99a0baa46372023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040066
application number: ANDA040066
Sulfacetamide SodiumSULFACETAMIDE SODIUMProficient Rx LP2b4f125c-338e-479f-8feb-b82324230c652022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040066
application number: ANDA040066
Sulfacetamide SodiumSULFACETAMIDE SODIUMAsclemed USA, Inc.129d5dd9-32a4-4398-862d-820cd44684482020-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040066
application number: ANDA040066

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSNd3709517-7eec-44cf-be71-2ce1ac9f08715
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDd3709517-7eec-44cf-be71-2ce1ac9f08715
1006120sulfacetamide sodium 10 % Eye DropsSYd3709517-7eec-44cf-be71-2ce1ac9f08715
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSYd3709517-7eec-44cf-be71-2ce1ac9f08715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9010-35300290100315 mL in 1 BOTTLE, DROPPER (53002-9010-3) 15 ml2021-05-010000-00-00NoNoCurrent