Home NDC 68071-3718 Diclofenac Potassium
Product NDC 68071-3718
11-digit product format 680713718
Labeler code 68071
Product ID 68071-3718_26a8f7fc-92d9-9d82-e063-6394a90aa3af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA075463
Marketing category ANDA
Marketing start 2021-09-15
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 42 .
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 A075463-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1999-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075463-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1999-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1999-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1999-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1999-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075463-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB RS 1999-07-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 68071-3718-3 Diclofenac Potassium 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3718 DICLOFENAC POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20241114_26a8f723-2a8e-8a5a-e063-6394a90a7bae.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 Diclofenac Potassium DICLOFENAC POTASSIUM Marlex Pharmaceuticals, Inc. 30c7197b-7110-d8a7-e063-6394a90addfb 2025-03-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075463 application number: ANDA075463 Diclofenac Potassium DICLOFENAC POTASSIUM Archis Pharma LLC 0d83cab3-c698-4763-9e77-27d72ba94e30 2024-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075463 application number: ANDA075463 Diclofenac Potassium DICLOFENAC POTASSIUM NuCare Pharmaceuticals, Inc. 26a8f723-2a8e-8a5a-e063-6394a90a7bae 2024-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075463 application number: ANDA075463 ndc (product): 68071-3718
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-3718-3 68071371803 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3718-3) 2024-11-11 No No Current