Home NDC 61314-701 Sulfacetamide Sodium
Product NDC 61314-701
11-digit product format 613140701
Labeler code 61314
Product ID 61314-701_6936177e-fec2-4ec0-b81d-af6d0bd43dc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfacetamide Sodium
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Sandoz Inc.
Application ANDA089560
Marketing category ANDA
Marketing start 2003-03-25
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61314-701-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61314-701-01 f5e01cc5f278…a2eaf40c39c3…
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-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 · 42 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 2026-08-18 06:07:40 2026-07 A089560-001 SULFACETAMIDE SODIUM 10% SOLUTION/DROPS / OPHTHALMIC AT 1988-10-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 METHYLCELLULOSE (100 CPS) INACTIVE INGREDIENT 4GFU244C4J SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 METHYLCELLULOSE (4000 CPS) INACTIVE INGREDIENT MRJ667KA5E SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] 4 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.] 4 SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 METHYLCELLULOSE (4000 CPS) INACTIVE INGREDIENT MRJ667KA5E SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.] 2 sulfacetamide sodium ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1 sulfacetamide ACTIVE MOIETY 4965G3J0F5 SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 METHYLCELLULOSE (100 CPS) INACTIVE INGREDIENT 4GFU244C4J SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 METHYLCELLULOSE (100 CPS) INACTIVE INGREDIENT 4GFU244C4J SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1 sodium thiosulfate INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] 1 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-701 SULFACETAMIDE SODIUM SOLUTION [SANDOZ INC.] 6 Legacy NDC 20220217_5530fb5f-728b-4a10-a345-01cd749a2684.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 61314-701-01 61314070101 15 mL in 1 BOTTLE, PLASTIC (61314-701-01) 15 ml 2003-03-25 0000-00-00 No No Current