Diclofenac Sodium

Product NDC
70518-2715
11-digit product format
705182715
Labeler code
70518
Product ID
70518-2715_b0ee1481-c629-2c40-e053-2995a90ae83c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077863
Marketing category
ANDA
Marketing start
2020-04-30
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2715DDiscontinued by firm2026-08-03
excluded packagepackage70518-271570518-2715-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-271570518-2715-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-271570518-2715-2DDiscontinued 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2715-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2715-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2715-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2715-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2715-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2715-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2715-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2715-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2715-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2715-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2715-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2715-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2715-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2715-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2715-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2715-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2715-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2715-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2715-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2715-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2715-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2715-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2715-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2715-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2715-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2715-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2715-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2715-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2715-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2715-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2715-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2715-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2715-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2715-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2715-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2715-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70518-2715-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70518-2715-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70518-2715-2IInactivated 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 packagepackage70518-2715-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70518-2715-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70518-2715-2IInactivated 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 packagepackage70518-2715-0IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70518-2715-1IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70518-2715-2IInactivated by FDAbd6a592717d7…303034d00443…

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
A077863-003DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077863-003AB

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 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 UTC2026-02A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2007-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2007-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2007-06-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077863-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALABRS2007-06-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077863-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077863-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077863-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077863-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077863-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077863-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077863-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077863-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077863-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077863-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077863-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077863-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077863-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077863-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077863-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077863-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077863-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077863-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077863-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077863-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077863-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077863-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077863-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077863-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077863-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077863-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077863-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077863-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077863-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077863-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077863-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077863-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077863-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077863-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077863-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077863-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077863-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077863-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077863-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077863-003AB1cb3db0bc1861…

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.681b6b25-4a28-44f2-8042-d5e01a5021162026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packagingdbb1489d-b690-4e53-905d-7fb07ad263b32026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMSt. Mary's Medical Park Pharmacy5f4b69de-8ddd-26c5-e053-2a91aa0ab3262026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1eb7a7bb-c524-4168-8ade-4601dc11533b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.ed1b5ec7-2812-4a81-90d1-953baa0b0ec82026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMSportpharm LLCe9ec5462-939a-4022-8946-5d81869a62772026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC47ce6fab-be1d-0076-e063-6294a90add632026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMBluePoint Laboratoriesfeb1541a-de83-47dd-be03-c433765273182025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMCoupler LLC2ce0741a-7bc7-8aec-e063-6294a90ae9ef2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.62edf474-9c16-d535-e053-2991aa0a4a092025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac DRDICLOFENACAdvanced Rx of Tennessee, LLCaf8a30fb-ead8-7e29-e053-2a95a90a040f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions50efc183-dd3e-4eb7-ba5c-c42fd76e0b652023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077863
application number: ANDA077863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2715-07051827150090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2715-0) 2020-04-300000-00-00NoNoCurrent
70518-2715-17051827150160 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2715-1) 2020-06-030000-00-00NoNoCurrent
70518-2715-27051827150230 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2715-2) 2020-07-090000-00-00NoNoCurrent