Home NDC 0480-9435 Diclofenac potassium
Product NDC 0480-9435
11-digit product format 004809435
Labeler code 0480
Product ID 0480-9435_40461510-7592-d588-e063-6394a90a8b9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac potassium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TEVA PHARMACEUTICALS, INC.
Application ANDA204648
Marketing category ANDA
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 A204648-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204648-001 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 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204648-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2016-02-23 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 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 0480-9435-89 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 0480-9435 DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20220324_d9685883-9d0b-81da-e053-2a95a90ab8d8.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 · 2 matching rows.
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 0480-9435-89 00480943589 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-9435-89) 2022-03-24 0000-00-00 No No Current