Home NDC 55700-591 Diclofenac Sodium
Product NDC 55700-591
11-digit product format 557000591
Labeler code 55700
Product ID 55700-591_05da3eba-6809-41fc-b02d-a357a57e4b09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION
Route TOPICAL
Labeler Quality Care Products LLC
Application ANDA202769
Marketing category ANDA
Marketing start 2018-03-09
Marketing end 2028-10-19
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
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 A202769-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08
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 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2015-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202769-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT 2015-07-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Sodium 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 55700-591-15 Diclofenac Sodium 1 in 1 CARTON SOLUTION 1 5 55700-591-15 Diclofenac Sodium 150 mL in 1 BOTTLE SOLUTION 150 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55700-591 DICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [QUALITY CARE PRODUCTS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230302_94422b85-28ed-477f-853a-71d1d6cf17d5.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 Marketing end Sample Exclude flag Status 55700-591-15 55700059115 1 BOTTLE in 1 CARTON (55700-591-15) / 150 mL in 1 BOTTLE 1 bottle 2018-03-09 2028-10-19 No No Current