Home NDC 63629-4108 Diclofenac Potassium
Product NDC 63629-4108
11-digit product format 636294108
Labeler code 63629
Product ID 63629-4108_37d9b7c1-4bf8-44ed-8d48-bd1ee6efd72c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075219
Marketing category ANDA
Marketing start 1998-08-11
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 A075219-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 1998-08-06 caaa826d4ba7…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…
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4108-1 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-2 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-3 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-4 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-5 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-6 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-7 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-8 2020-07-06 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-1 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-2 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-3 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-4 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-5 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-6 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-7 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only 63629-4108-8 2020-01-31 Diclofenac Potassium Tablets, USP 50 mg Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-4108-1 Diclofenac Potassium 20 in 1 BOTTLE TABLET, FILM COATED 20 15 63629-4108-2 Diclofenac Potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 15 63629-4108-3 Diclofenac Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 15 63629-4108-4 Diclofenac Potassium 60 in 1 BOTTLE TABLET, FILM COATED 60 15 63629-4108-5 Diclofenac Potassium 45 in 1 BOTTLE TABLET, FILM COATED 45 15 63629-4108-6 Diclofenac Potassium 58 in 1 BOTTLE TABLET, FILM COATED 58 15 63629-4108-7 Diclofenac Potassium 18 in 1 BOTTLE TABLET, FILM COATED 18 15 63629-4108-8 Diclofenac Potassium 120 in 1 BOTTLE TABLET, FILM COATED 120 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DICLOFENAC POTASSIUM ACTIVE INGREDIENT L4D5UA6CB4 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 TRICALCIUM PHOSPHATE INACTIVE INGREDIENT K4C08XP666 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-4108 DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 15 Current NDC, Legacy NDC, 8 package rows 20231004_717341fc-e067-0005-215c-053f6d12e0d1.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 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 ndc (product): 63629-4108
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 63629-4108-1 63629410801 20 TABLET, FILM COATED in 1 BOTTLE (63629-4108-1) 2009-12-02 0000-00-00 No No Current 63629-4108-2 63629410802 90 TABLET, FILM COATED in 1 BOTTLE (63629-4108-2) 2010-04-20 0000-00-00 No No Current 63629-4108-3 63629410803 30 TABLET, FILM COATED in 1 BOTTLE (63629-4108-3) 2010-05-25 0000-00-00 No No Current 63629-4108-4 63629410804 60 TABLET, FILM COATED in 1 BOTTLE (63629-4108-4) 2011-01-06 0000-00-00 No No Current 63629-4108-5 63629410805 45 TABLET, FILM COATED in 1 BOTTLE (63629-4108-5) 2021-12-22 0000-00-00 No No Current 63629-4108-6 63629410806 58 TABLET, FILM COATED in 1 BOTTLE (63629-4108-6) 2021-12-22 0000-00-00 No No Current 63629-4108-7 63629410807 18 TABLET, FILM COATED in 1 BOTTLE (63629-4108-7) 2021-12-22 0000-00-00 No No Current 63629-4108-8 63629410808 120 TABLET, FILM COATED in 1 BOTTLE (63629-4108-8) 2021-12-22 0000-00-00 No No Current