Diclofenac Sodium

Product NDC
68001-200
11-digit product format
680010200
Labeler code
68001
Product ID
68001-200_964b1f7e-8c60-4c05-8542-c987cee5ca5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA074394
Marketing category
ANDA
Marketing start
2014-02-24
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
75 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
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68001-200DDiscontinued by firm2026-08-03
excluded packagepackage68001-20068001-200-00DDiscontinued by firm2026-08-03
excluded packagepackage68001-20068001-200-03DDiscontinued by firm2026-08-03
excluded packagepackage68001-20068001-200-06DDiscontinued by firm2026-08-03
excluded packagepackage68001-20068001-200-08DDiscontinued by firm2026-08-03

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-200-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-200-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-200-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-200-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-200-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-200-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-200-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-200-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-200-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-200-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-200-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-200-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-200-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-200-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-200-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-200-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-200-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-200-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-200-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-200-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-200-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-200-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-200-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-200-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-200-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-200-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-200-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-200-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-200-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-200-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-200-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-200-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-200-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-200-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-200-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-200-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-200-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-200-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-200-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-200-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-200-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-200-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-200-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-200-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-200-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-200-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-200-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-200-00557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074394-001DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS1995-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS1995-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS1995-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074394-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL1995-11-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074394-001AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A074394-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074394-001AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-200-00EA - Each68001-200735419c3-12d2-47ae-a63c-3c729ed19dc712014-04-03
68001-200-03EA - Each68001-2006192dc75-8a99-4ae8-ad21-f576338992bd12014-11-05
68001-200-06EA - Each68001-20006fedf12-9414-4698-9134-2b2edfee72c612014-11-05
68001-200-08EA - Each68001-200542d4418-80c7-4688-a548-5cb9ed84516812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4