Home NDC 50090-3568 Diclofenac Sodium
Product NDC 50090-3568
11-digit product format 500903568
Labeler code 50090
Product ID 50090-3568_3f758075-7120-495a-9e3b-6370828dc758
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application ANDA078031
Marketing category ANDA
Marketing start 2008-02-14
Substance DICLOFENAC SODIUM
Active strength 1 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
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 A078031-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078031-001 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 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078031-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2008-02-06 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 Diclofenac Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854801 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 50090-3568-0 Diclofenac Sodium 5 mL in 1 BOTTLE SOLUTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3568 DICLOFENAC SODIUM SOLUTION [A-S MEDICATION SOLUTIONS] 6 Current NDC, 1 package rows 20230317_3a520306-fe3e-4830-963f-04b080db3abc.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-3568-0 50090356800 5 mL in 1 BOTTLE (50090-3568-0) 5 ml 2018-08-31 No No Current