Home NDC 62135-469 Diclofenac Potassium
Product NDC 62135-469
11-digit product format 621350469
Labeler code 62135
Product ID 62135-469_459be997-2951-a7cf-e063-6394a90ad491
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Potassium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA210078
Marketing category ANDA
Marketing start 2022-11-21
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 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 A210078-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210078-001 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 2026-08-18 06:07:40 2026-07 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL 2019-12-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210078-001 DICLOFENAC POTASSIUM 25MG CAPSULE / ORAL AB 2019-12-03 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 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 62135-469-12 Diclofenac Potassium 120 in 1 BOTTLE CAPSULE, LIQUID FILLED 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-469 DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241012_3a837a3e-10b2-4256-b515-80c863318ccb.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 Strides Pharma Science Limited 2184805c-b9b3-4be8-8726-4ce1b1197477 2026-06-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210078 application number: ANDA210078 Diclofenac Potassium DICLOFENAC POTASSIUM 25 MG PureTek Corporation 4a828eb5-0383-f524-e063-6394a90a8449 2026-04-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210078 application number: ANDA210078 Diclofenac Potassium DICLOFENAC POTASSIUM Chartwell RX, LLC 3a837a3e-10b2-4256-b515-80c863318ccb 2025-12-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210078 application number: ANDA210078 ndc (product): 62135-469 Diclofenac Potassium DICLOFENAC POTASSIUM Lifsa Drugs LLC 90a0539a-7227-4b91-8b22-25b6f23ef35f 2025-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210078 application number: ANDA210078 diclofenac potassium DICLOFENAC POTASSIUM Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. d64537c8-e397-4d17-b95c-3092668260aa 2025-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210078 application number: ANDA210078
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-469-12 62135046912 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-469-12) 2023-02-12 No No Current