Home NDC 43386-016 DICLOFENAC SODIUM
Product NDC 43386-016
11-digit product format 433860016
Labeler code 43386
Product ID 43386-016_9d8e578d-3a5b-4d9d-bdac-618067779f81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DICLOFENAC SODIUM
Dosage form SOLUTION
Route TOPICAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA205878
Marketing category ANDA
Marketing start 2015-12-09
Substance DICLOFENAC SODIUM
Active strength 16.05 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 A205878-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205878-001 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 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205878-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-12-09 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 16.05 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 857700 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 43386-016-61 DICLOFENAC SODIUM 150 mL in 1 BOTTLE SOLUTION 150 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-016 DICLOFENAC SODIUM SOLUTION [LUPIN PHARMACEUTICALS,INC.] 3 Current NDC, 1 package rows 20240322_7559928e-eeb8-47e8-8a55-d59e06bbc737.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 Status 43386-016-61 43386001661 150 mL in 1 BOTTLE 150 ml Historical