Diclofenac Potassium

Product NDC
50090-0646
Requested package NDC
50090-0646-3
11-digit product format
500900646
Labeler code
50090
Product ID
50090-0646_202db51e-c67d-4867-8a69-3457a98907bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-064650090-0646-3IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
50090-0646-0Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED3013
50090-0646-1Diclofenac Potassium21 in 1 BOTTLETABLET, FILM COATED2113
50090-0646-3Diclofenac Potassium45 in 1 BOTTLETABLET, FILM COATED4513
50090-0646-4Diclofenac Potassium90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0646-0EA - Each50090-0646731288c8-8dcb-426e-bdda-5a0e23f8e70e12018-10-11
50090-0646-1EA - Each50090-06465b452fe2-6600-47cc-9e72-ddeae6f74e6612018-10-11
50090-0646-3EA - Each50090-0646d9e4ed7c-5bf0-40b2-b088-184db4c0718412018-10-11
50090-0646-4EA - Each50090-0646958d0bbc-7d6c-4add-a6a6-ad692c01a94412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0646DICLOFENAC POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Legacy NDC, 4 package rows20210616_29235691-2395-4ea1-892a-379c59e7d3c4.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 TabletPSN29235691-2395-4ea1-892a-379c59e7d3c413
855942diclofenac potassium 50 MG Oral TabletSCD29235691-2395-4ea1-892a-379c59e7d3c413
855942Diclofenac K+ 50 MG Oral TabletSY29235691-2395-4ea1-892a-379c59e7d3c413
855942Diclofenac Pot 50 MG Oral TabletSY29235691-2395-4ea1-892a-379c59e7d3c413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0646-35009006460345 TABLET, FILM COATED in 1 BOTTLE (50090-0646-3) 2014-11-280000-00-00NoNoCurrent