Home NDC 68788-8697 Diclofenac Potassium
Product NDC 68788-8697
11-digit product format 687888697
Labeler code 68788
Product ID 68788-8697_4304b6f9-79d2-46a6-9de7-e27eba8dc662
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA215585
Marketing category ANDA
Marketing start 2024-06-24
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 A215585-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215585-001 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.
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 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 a50c72e98297…
Observed Orange Book normalized TE 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 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 68788-8697-3 Diclofenac Potassium 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 68788-8697-6 Diclofenac Potassium 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 68788-8697-9 Diclofenac Potassium 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8697 DICLOFENAC POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 3 package rows 20250316_4f482f98-ef10-45d7-8e9f-9cf291d93092.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 REMEDYREPACK INC. c4976d69-ca06-4263-9240-6fd8b44a9b6d 2026-06-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM Bryant Ranch Prepack e29e7aea-0bcd-46e5-b011-fbaf5aa2244a 2026-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM AvKARE 21dc9953-4e6d-50f0-e063-6294a90ac4ef 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM Ingenus Pharmaceuticals, LLC 6926444f-0dca-4aeb-812e-755a83b149f4 2025-10-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM Preferred Pharmaceuticals Inc. 4f482f98-ef10-45d7-8e9f-9cf291d93092 2025-03-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 ndc (product): 68788-8697
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68788-8697-3 68788869703 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8697-3) 2024-06-24 No No Current 68788-8697-6 68788869706 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8697-6) 2024-06-24 No No Current 68788-8697-9 68788869709 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8697-9) 2024-06-24 No No Current