Home NDC 59390-149-05 Diclofenac
Product NDC 59390-149
Requested package NDC 59390-149-05
11-digit product format 593900149
Labeler code 59390
Product ID 59390-149_0561ff06-43b4-493e-93f7-b778fc829036
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Altaire Pharmaceuticals Inc.
Application ANDA203383
Marketing category ANDA
Marketing start 2015-11-16
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 59390-149 59390-149-05 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 59390-149 59390-149-05 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A203383-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203383-001 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 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203383-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2015-11-16 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
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 59390-149-02 Diclofenac 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 6 59390-149-02 Diclofenac 1 in 1 CARTON SOLUTION/ DROPS 1 6 59390-149-05 Diclofenac 1 in 1 CARTON SOLUTION/ DROPS 1 6 59390-149-05 Diclofenac 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59390-149 DICLOFENAC (DICLOFENAC SODIUM) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 4 package rows 20221206_5372866a-dab3-45c8-8c2a-755ca36c1791.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 Marketing start Marketing end Sample Exclude flag Status 59390-149-05 59390014905 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER 2015-11-16 0000-00-00 No No Current