Diclofenac Sodium

Product NDC
63629-1011
11-digit product format
636291011
Labeler code
63629
Product ID
63629-1011_22de8baa-1c5e-47c5-bc98-f6fba8e3a559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
50 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
2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1011DDiscontinued by firm2026-08-03
excluded packagepackage63629-101163629-1011-0DDiscontinued by firm2026-08-03
excluded packagepackage63629-101163629-1011-1DDiscontinued by firm2026-08-03
excluded packagepackage63629-101163629-1011-3DDiscontinued by firm2026-08-03
excluded packagepackage63629-101163629-1011-6DDiscontinued by firm2026-08-03
excluded packagepackage63629-101163629-1011-8DDiscontinued 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 2 · 66 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 packagepackage63629-1011-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1011-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1011-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1011-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1011-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1011-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1011-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1011-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1011-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1011-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1011-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1011-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1011-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1011-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1011-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1011-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1011-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1011-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1011-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1011-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1011-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1011-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1011-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1011-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1011-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1011-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1011-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1011-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1011-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1011-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1011-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1011-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1011-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1011-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1011-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1011-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1011-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1011-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1011-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1011-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1011-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1011-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1011-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1011-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1011-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1011-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1011-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1011-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1011-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1011-8ad56d346431e…cc804d4bbf1e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075185-001DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-002DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-003DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075185-001AB
A075185-002AB
A075185-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-138072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075185-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075185-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075185-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075185-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.ddd2278b-70be-41ca-8a84-e3fe0f1a15612026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.30c7e4fd-30af-4d28-a6ef-7386ff83cfb82026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.10991fe6-fafd-49af-9684-83b447c19c672026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium D/RDICLOFENAC SODIUM D/RDirectRx50886f90-8cd0-4d38-e063-6294a90a44e42026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.7e940ce5-0f82-4d07-b507-c644481879c12026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e947653c-6789-4c15-82c9-4b1402f6d6ac2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMRedpharm Drug4cd2e51b-2019-6eb6-e063-6294a90ad7ef2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions0cefb675-c54e-44eb-b35c-38354b77eddd2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions74011b00-7e2e-40a7-ab30-c05a205598142026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac SodiumDICLOFENAC SODIUMAvKARE19b4ff5c-adb7-a0d0-7ef2-4ae05047fd942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.14c1b1a1-bc06-4722-9612-e88ae52272bc2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCc16e7e43-3869-9fef-e053-2995a90a1fdb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCf2b7ea75-738b-54a8-e053-2995a90a00d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC47a7a294-55bb-8d19-e063-6394a90a54402025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions40388047-7fbe-49bf-bed8-e5087bed4e032025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions4a88f136-f7c7-47d7-b85d-8a2f9f118f092025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions58063c26-86fe-4f03-97ef-51706e5f40542025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC4539e9e7-5d82-3b36-e063-6394a90a13962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLCb8072af2-9940-4827-9fbd-de46ad8bf9292025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1011-0636291011001000 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-1011-0) 2013-01-080000-00-00NoNoCurrent
63629-1011-163629101101100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-1011-1) 2013-01-080000-00-00NoNoCurrent
63629-1011-363629101103300 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-1011-3) 2013-01-080000-00-00NoNoCurrent
63629-1011-66362910110660 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-1011-6) 2013-01-080000-00-00NoNoCurrent
63629-1011-863629101108800 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-1011-8) 2013-01-080000-00-00NoNoCurrent