Home NDC 69315-275 Diclofenac Potassium
Product NDC 69315-275
11-digit product format 693150275
Labeler code 69315
Product ID 69315-275_9f4d938d-3f9c-41b0-bb9b-82fd4487cf66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Potassium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Leading Pharma, LLC
Application NDA022202
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-03-24
Substance DICLOFENAC POTASSIUM
Active strength 25 mg/1
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 N022202-001 ZIPSOR DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022202-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022202-001 7662858 2029-02-24 U-1035 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 N022202-001 7939518 2029-02-24 U-980 2011-05-19 N022202-001 8110606 2029-02-24 U-980 2012-02-13 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 N022202-001 9561200 2029-02-24 U-1482 2017-02-14
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 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022202-001 ZIPSOR 25MG CAPSULE / ORAL AB RLD, RS 2009-06-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 254 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022202-001 7662858 2029-02-24 U-1035 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022202-001 7939518 2029-02-24 U-980 2011-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022202-001 8110606 2029-02-24 U-980 2012-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022202-001 9561200 2029-02-24 U-1482 2017-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 7662858 2029-02-24 U-1035 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 7939518 2029-02-24 U-980 2011-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 8110606 2029-02-24 U-980 2012-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022202-001 9561200 2029-02-24 U-1482 2017-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022202-001 7662858 2029-02-24 U-1035 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022202-001 7939518 2029-02-24 U-980 2011-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022202-001 8110606 2029-02-24 U-980 2012-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022202-001 9561200 2029-02-24 U-1482 2017-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 7662858 2029-02-24 U-1035 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 7939518 2029-02-24 U-980 2011-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 8110606 2029-02-24 U-980 2012-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022202-001 9561200 2029-02-24 U-1482 2017-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 7662858 2029-02-24 U-1035 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 7939518 2029-02-24 U-980 2011-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 8110606 2029-02-24 U-980 2012-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022202-001 9561200 2029-02-24 U-1482 2017-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 7662858 2029-02-24 U-1035 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 7939518 2029-02-24 U-980 2011-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 8110606 2029-02-24 U-980 2012-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 8623920 2029-02-24 U-1482 2014-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022202-001 9561200 2029-02-24 U-1482 2017-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022202-001 7662858 2029-02-24 U-1035 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022202-001 7884095 2029-02-24 U-1111 2011-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022202-001 7939518 2029-02-24 U-980 2011-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022202-001 8110606 2029-02-24 U-980 2012-02-13 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC POTASSIUM 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L4D5UA6CB4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858342 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 69315-275-20 Diclofenac Potassium 120 in 1 BOTTLE CAPSULE, LIQUID FILLED 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-275 DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [LEADING PHARMA, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20250317_698690a7-4978-4457-b123-0a670bbab481.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIPSOR DICLOFENAC POTASSIUM Assertio Therapeutics, Inc. c982eca0-fc41-11e1-a9c8-0002a5d5c51b 2025-09-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022202 application number: NDA022202 Diclofenac Potassium DICLOFENAC POTASSIUM Leading Pharma, LLC 698690a7-4978-4457-b123-0a670bbab481 2025-03-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022202 application number: NDA022202 ndc (product): 69315-275 Diclofenac Potassium DICLOFENAC POTASSIUM Bryant Ranch Prepack 69ab6f91-5770-480c-8bd1-8c1f1f8bfdb5 2025-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022202 application number: NDA022202
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 69315-275-20 69315027520 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20) 2022-03-24 0000-00-00 No No Current