Home NDC 68788-9871 Sulfacetamide Sodium
Product NDC 68788-9871
11-digit product format 687889871
Labeler code 68788
Product ID 68788-9871_fe2e1b1d-4502-43a2-90f5-7b06d074ac1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulfacetamide sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Preferred Pharmaceuticals, Inc
Application ANDA040066
Marketing category ANDA
Marketing start 2012-02-28
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 A040066-001 SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040066-001 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 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT RS 1994-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040066-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1994-12-28 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 68788-9871-1 Sulfacetamide Sodium 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 METHYLCELLULOSE (100 CPS) INACTIVE INGREDIENT 4GFU244C4J SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9871 SULFACETAMIDE SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC] 9 Current NDC, Legacy NDC, 1 package rows 20240816_cf0cc763-49b5-435d-852b-e7617c8d3286.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sulfacetamide Sodium SULFACETAMIDE SODIUM A-S Medication Solutions f212af23-be3d-4e82-9f6f-5ddce12a89da 2026-03-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040066 application number: ANDA040066 Sulfacetamide Sodium SULFACETAMIDE SODIUM Preferred Pharmaceuticals, Inc cf0cc763-49b5-435d-852b-e7617c8d3286 2025-09-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 68788-9871 Sulfacetamide Sodium SULFACETAMIDE SODIUM NuCare Pharmaceuticals,Inc. 9910ec80-e37c-6a83-e053-2995a90a8237 2024-06-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040066 application number: ANDA040066 Sulfacetamide Sodium SULFACETAMIDE SODIUM Bausch & Lomb Incorporated 6c1b2658-e756-4f31-9bc8-f99a0baa4637 2023-08-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040066 application number: ANDA040066 Sulfacetamide Sodium SULFACETAMIDE SODIUM Proficient Rx LP 2b4f125c-338e-479f-8feb-b82324230c65 2022-08-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040066 application number: ANDA040066 Sulfacetamide Sodium SULFACETAMIDE SODIUM Asclemed USA, Inc. 129d5dd9-32a4-4398-862d-820cd4468448 2020-10-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040066 application number: ANDA040066
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 68788-9871-1 68788987101 15 mL in 1 BOTTLE, DROPPER (68788-9871-1) 15 ml 2012-02-28 0000-00-00 No No Current