Diclofenac Potassium

Product NDC
53002-1176
11-digit product format
530021176
Labeler code
53002
Product ID
53002-1176_30dc3f72-2350-430c-be55-a3132e6936a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075219
Marketing category
ANDA
Marketing start
1998-08-11
Marketing end
0000-00-00
Substance
DICLOFENAC POTASSIUM
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-1176IInactivated by FDA2026-08-17
excluded packagepackage53002-117653002-1176-3IInactivated by FDA2026-08-17

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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-1176-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-1176-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-1176-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-1176-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-1176-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-1176-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1176-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1176-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1176-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-1176-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-1176-3IInactivated by FDA9bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075219-001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075219-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-063f01610625f2…
2019-09-15 20:21 UTC2019-09A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075219-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-08-06e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075219-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075219-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075219-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075219-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075219-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075219-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075219-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075219-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075219-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075219-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075219-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075219-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075219-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075219-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075219-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075219-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075219-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075219-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075219-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075219-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075219-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075219-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075219-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075219-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075219-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075219-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075219-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075219-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075219-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075219-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075219-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075219-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075219-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075219-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075219-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075219-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075219-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075219-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075219-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075219-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1176-3Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1176DICLOFENAC POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_90c6d882-aea2-439a-a3c1-53255d12ae94.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac PotassiumDICLOFENAC POTASSIUMPreferred Pharmaceuticals Inc.8dfaa874-d6cf-4107-b57f-25dab02aa2012025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075219
application number: ANDA075219
Diclofenac PotassiumDICLOFENAC POTASSIUMPD-Rx Pharmaceuticals, Inc.08e41a9d-644c-4ac6-aba3-38d7c3f36d362025-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075219
application number: ANDA075219
Diclofenac PotassiumDICLOFENAC POTASSIUMTeva Pharmaceuticals USA, Inc.77b60a0c-e49a-4ad4-abb1-b662c24ab7822024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075219
application number: ANDA075219
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals, Inc.3da9e463-1b2f-54c0-e054-00144ff88e882024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075219
application number: ANDA075219
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack717341fc-e067-0005-215c-053f6d12e0d12023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075219
application number: ANDA075219

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN90c6d882-aea2-439a-a3c1-53255d12ae945
855942diclofenac potassium 50 MG Oral TabletSCD90c6d882-aea2-439a-a3c1-53255d12ae945
855942Diclofenac K+ 50 MG Oral TabletSY90c6d882-aea2-439a-a3c1-53255d12ae945
855942Diclofenac Pot 50 MG Oral TabletSY90c6d882-aea2-439a-a3c1-53255d12ae945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1176-35300211760330 TABLET, FILM COATED in 1 BOTTLE (53002-1176-3) 2018-10-010000-00-00NoNoCurrent