FDA.reportPublic FDA data

Sulfacetamide Sodium

Product NDC
0574-4190
11-digit product format
005744190
Labeler code
0574
Product ID
0574-4190_b50202dd-c913-4ae7-afbb-74be0db2ef80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA080029
Marketing category
ANDA
Marketing start
2014-08-13
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/g
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 productproduct0574-4190DDiscontinued by firm2026-08-17
excluded packagepackage0574-41900574-4190-35DDiscontinued by firm2026-08-17

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
A080029-001SULFACETAMIDE SODIUMSULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICApproved before 1982

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 06:07:402026-07A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080029-001SULFACETAMIDE SODIUM10%OINTMENT / OPHTHALMICRS, Approved before 1982e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4190-35GM - Gram0574-4190288cc548-3196-44ae-b718-7c52458a7f3212014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USULFACETAMIDE SODIUM OINTMENT [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4190SULFACETAMIDE SODIUM OINTMENT [PADAGIS US LLC]4Legacy NDC20241109_558280c6-893e-4645-9018-40c69be936d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4190-35005744190351 TUBE in 1 CARTON (0574-4190-35) > 3.5 g in 1 TUBE1 tube2014-08-130000-00-00NoNoCurrent