Home NDC 76420-076-15 Sulfacetamide Sodium
Product NDC 76420-076
Requested package NDC 76420-076-15
11-digit product format 764200076
Labeler code 76420
Product ID 76420-076_ead2d6e4-62f6-3b3c-e053-2a95a90a4ccd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfacetamide Sodium
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Asclemed USA, Inc.
Application ANDA089560
Marketing category ANDA
Marketing start 2003-03-25
Substance SULFACETAMIDE SODIUM
Active strength 100 mg/mL
Pharmacologic classes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089560-001 SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089560-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sulfacetamide Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1006120 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76420-076-15 Sulfacetamide Sodium 15 mL in 1 BOTTLE, PLASTIC SOLUTION 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-076 SULFACETAMIDE SODIUM SOLUTION [ASCLEMED USA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20221013_c4c29e13-8303-4a9a-bb47-d7413eaf2f26.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76420-076-15 76420007615 15 mL in 1 BOTTLE, PLASTIC (76420-076-15) 15 ml 2020-01-16 0000-00-00 No No Current