Diclofenac Sodium

Product NDC
66336-238
11-digit product format
663360238
Labeler code
66336
Product ID
66336-238_ef637460-8812-461e-a394-21a610bbebd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
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
E
Listing certified through
2017-12-31
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 productproduct66336-238IInactivated by FDA2026-08-07
excluded packagepackage66336-23866336-238-20IInactivated by FDA2026-08-07
excluded packagepackage66336-23866336-238-30IInactivated by FDA2026-08-07
excluded packagepackage66336-23866336-238-60IInactivated by FDA2026-08-07
excluded packagepackage66336-23866336-238-90IInactivated by FDA2026-08-07

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 · 110 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 packagepackage66336-238-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-238-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-238-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-238-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-238-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-238-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-238-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-238-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-238-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-238-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-238-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-238-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-238-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-238-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-238-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-238-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-238-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-238-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-238-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-238-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-238-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-238-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-238-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-238-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-238-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-238-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-238-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-238-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-238-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-238-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-238-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-238-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-238-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-238-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-238-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-238-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-238-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-238-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-238-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-238-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-238-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-238-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-238-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-238-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-238-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-238-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-238-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-238-60557ba5c1ecfa…9c80585c8c6e…

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
A074514-001DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26
A074514-002DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074514-001AB
A074514-002AB

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 UTC2026-02A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074514-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074514-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074514-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074514-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074514-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074514-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074514-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074514-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074514-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074514-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074514-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074514-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074514-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074514-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074514-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074514-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074514-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074514-002AB1782e0a99824c…

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-238-20Diclofenac Sodium20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE202
66336-238-30Diclofenac Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE302
66336-238-60Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE602
66336-238-90Diclofenac Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-238-20EA - Each66336-2389ca2c285-23fe-4bc6-b501-432499933eff12013-11-04
66336-238-60EA - Each66336-23899cb8789-7e6d-4058-8851-ec34e84b16b412013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-238DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 4 package rows20131029_1877c2fb-39f7-45e3-b7f0-eb834ee273e4.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMGolden State Medical Supply, Inc.c1d87003-f54b-4381-9e11-1c39ea2d9eb32026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.663a3dbc-a631-4046-8852-ec619c41c81d2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.87d5a720-f154-4c4b-b2d4-0ae58455dda02025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf5b4e308-c156-4865-95ee-1a8e267535ba2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.a57b897e-0cbe-4ac3-969f-b00357a0cfa82024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP77c3cb56-c071-4d92-a0d6-022417a27de42019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMAphena Pharma Solutions - Tennessee, LLCe4af374a-1281-46af-a0a9-48820db6c9472018-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN1877c2fb-39f7-45e3-b7f0-eb834ee273e42
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD1877c2fb-39f7-45e3-b7f0-eb834ee273e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-238-206633602382020 in 1 BOTTLE, PLASTICHistorical
66336-238-306633602383030 in 1 BOTTLE, PLASTICHistorical
66336-238-606633602386060 in 1 BOTTLE, PLASTICHistorical
66336-238-906633602389090 in 1 BOTTLE, PLASTICHistorical