Home NDC 50090-2454 Diclofenac Sodium
Product NDC 50090-2454
11-digit product format 500902454
Labeler code 50090
Product ID 50090-2454_98e8ede7-aa2f-4dfa-90de-b7a9c5b828b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application ANDA078792
Marketing category ANDA
Marketing start 2007-12-28
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 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-2454-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-2454-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-2454-0 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-2454-0 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-2454-0 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2454-0 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A078792-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078792-001 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 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2454-0 Diclofenac Sodium 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 15 50090-2454-0 Diclofenac Sodium 1 in 1 CARTON SOLUTION/ DROPS 1 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2454 DICLOFENAC SODIUM SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] 15 Current NDC, Legacy NDC, 2 package rows 20250210_5d74488c-e092-415d-b19b-05318380d9b1.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 Marketing start Sample Exclude flag Status 50090-2454-0 50090245400 1 BOTTLE, DROPPER in 1 CARTON (50090-2454-0) / 5 mL in 1 BOTTLE, DROPPER 2016-08-12 No No Current