Home NDC 68788-8411 Diclofenac Potassium
Product NDC 68788-8411
11-digit product format 687888411
Labeler code 68788
Product ID 68788-8411_8dfaa874-d6cf-4107-b57f-25dab02aa201
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA075219
Marketing category ANDA
Marketing start 2025-04-30
Substance DICLOFENAC POTASSIUM
Active strength 50 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 A075219-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075219-001 AB
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 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 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 Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC POTASSIUM 50 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 855942 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 68788-8411-3 Diclofenac Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 1 68788-8411-6 Diclofenac Potassium 60 in 1 BOTTLE TABLET, FILM COATED 60 1 68788-8411-9 Diclofenac Potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8411 DICLOFENAC POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 3 package rows 20250502_8dfaa874-d6cf-4107-b57f-25dab02aa201.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac Potassium DICLOFENAC POTASSIUM Preferred Pharmaceuticals Inc. 8dfaa874-d6cf-4107-b57f-25dab02aa201 2025-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075219 application number: ANDA075219 ndc (product): 68788-8411 Diclofenac Potassium DICLOFENAC POTASSIUM PD-Rx Pharmaceuticals, Inc. 08e41a9d-644c-4ac6-aba3-38d7c3f36d36 2025-03-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075219 application number: ANDA075219 Diclofenac Potassium DICLOFENAC POTASSIUM Teva Pharmaceuticals USA, Inc. 77b60a0c-e49a-4ad4-abb1-b662c24ab782 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075219 application number: ANDA075219 Diclofenac Potassium DICLOFENAC POTASSIUM NuCare Pharmaceuticals, Inc. 3da9e463-1b2f-54c0-e054-00144ff88e88 2024-08-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075219 application number: ANDA075219 Diclofenac Potassium DICLOFENAC POTASSIUM Bryant Ranch Prepack 717341fc-e067-0005-215c-053f6d12e0d1 2023-10-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075219 application number: ANDA075219
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68788-8411-3 68788841103 30 TABLET, FILM COATED in 1 BOTTLE (68788-8411-3) 2025-04-30 No No Current 68788-8411-6 68788841106 60 TABLET, FILM COATED in 1 BOTTLE (68788-8411-6) 2025-04-30 No No Current 68788-8411-9 68788841109 90 TABLET, FILM COATED in 1 BOTTLE (68788-8411-9) 2025-04-30 No No Current