Diclofenac Sodium

Product NDC
68151-2481
11-digit product format
681512481
Labeler code
68151
Product ID
68151-2481_000e0356-cc97-4c3c-a0f7-57dcf0c52e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA074376
Marketing category
ANDA
Marketing start
1995-09-28
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
25 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
E
Listing certified through
2018-12-31
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 productproduct68151-2481IInactivated by FDA2026-08-03
excluded packagepackage68151-248168151-2481-0IInactivated by FDA2026-08-03

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 · 44 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 packagepackage68151-2481-0IInactivated 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 packagepackage68151-2481-0IInactivated 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 packagepackage68151-2481-0IInactivated 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 packagepackage68151-2481-0IInactivated 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 packagepackage68151-2481-0IInactivated 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 packagepackage68151-2481-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-2481-0IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-2481-0IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-2481-0IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-2481-0IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-2481-0IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-2481-0IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-2481-0IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-2481-0IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-2481-0IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-2481-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-2481-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-2481-0IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-2481-0IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-2481-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-2481-0EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-2481-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074376-001DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28
A074376-002DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS1995-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS1995-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074376-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORAL1995-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A074376-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL1995-09-28782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074376-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074376-002AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A074376-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074376-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074376-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074376-002AB1ea99ee380514…

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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2481-02020-07-22C16284748780-1ab0b4bfd-9c0b-d255-e053-dadaa90ae591Diclofenac Sodium Delayed-release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2481-0Diclofenac Sodium1 in 1 PACKAGETABLET, DELAYED RELEASE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2481DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140708_a65aa738-8ce2-4276-8e54-5ecf4f461d3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSNa65aa738-8ce2-4276-8e54-5ecf4f461d3a2
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCDa65aa738-8ce2-4276-8e54-5ecf4f461d3a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2481-0681512481001 in 1 PACKAGEHistorical