Diclofenac Sodium

Product NDC
71335-1238
11-digit product format
713351238
Labeler code
71335
Product ID
71335-1238_72d96aa7-bd3d-44e0-98cf-b65a738221d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076201
Marketing category
ANDA
Marketing start
2002-11-06
Substance
DICLOFENAC SODIUM
Active strength
100 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
2026-12-31
Current FDA listing
Yes

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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1238DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-7DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-8DDiscontinued by firm2026-08-17
excluded packagepackage71335-123871335-1238-9DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076201-001DICLOFENAC SODIUMDICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076201-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-063f01610625f2…
2019-09-15 20:21 UTC2019-09A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076201-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALABRS2002-11-06e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076201-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076201-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076201-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076201-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076201-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076201-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076201-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076201-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076201-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076201-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076201-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076201-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076201-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076201-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076201-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076201-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076201-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076201-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076201-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076201-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076201-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076201-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076201-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076201-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076201-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076201-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076201-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076201-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076201-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076201-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076201-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076201-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076201-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076201-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076201-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076201-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076201-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076201-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076201-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076201-001AB1e64feba35796…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1238-1Diclofenac Sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE605
71335-1238-2Diclofenac Sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE305
71335-1238-3Diclofenac Sodium15 in 1 BOTTLETABLET, EXTENDED RELEASE155
71335-1238-4Diclofenac Sodium14 in 1 BOTTLETABLET, EXTENDED RELEASE145
71335-1238-5Diclofenac Sodium10 in 1 BOTTLETABLET, EXTENDED RELEASE105
71335-1238-6Diclofenac Sodium21 in 1 BOTTLETABLET, EXTENDED RELEASE215
71335-1238-7Diclofenac Sodium90 in 1 BOTTLETABLET, EXTENDED RELEASE905
71335-1238-8Diclofenac Sodium120 in 1 BOTTLETABLET, EXTENDED RELEASE1205
71335-1238-9Diclofenac Sodium7 in 1 BOTTLETABLET, EXTENDED RELEASE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1238-1EA - Each71335-12385a3c9457-cfc0-458b-b007-0392d1ef0dea12019-11-12
71335-1238-2EA - Each71335-123841d8792e-83ba-4cd8-a074-a9f7832aaab612023-12-05
71335-1238-4EA - Each71335-123810e03210-f8bb-4b12-af7c-ba4528cfbd0c12023-12-05
71335-1238-5EA - Each71335-123869e6c5a4-7172-4e6e-b1bc-cc123fb56a0d12023-12-05
71335-1238-6EA - Each71335-12380492b843-12ec-492a-8e93-29104003423412020-09-14
71335-1238-9EA - Each71335-1238094e29d9-ad19-44a7-b33f-74c00d4d720b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1238DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20231108_e9ece848-3cd3-4a75-be88-d131775016a7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMST. MARY'S MEDICAL PARK PHARMACY4ddd7e34-e5f4-8f05-e063-6294a90a70aa2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076201
application number: ANDA076201
Diclofenac SodiumDICLOFENAC SODIUMEdenbridge Pharmaceuticals LLC.bd25a2b1-a4d5-4893-97d1-efdcd414a97d2026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076201
application number: ANDA076201
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.0d1d19e5-4ffe-af95-e063-6394a90a7abf2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076201
application number: ANDA076201
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, LLC.26e44aa5-cfcd-f10b-e063-6394a90a4dcf2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076201
application number: ANDA076201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNe9ece848-3cd3-4a75-be88-d131775016a75
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDe9ece848-3cd3-4a75-be88-d131775016a75
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYe9ece848-3cd3-4a75-be88-d131775016a75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1238-17133512380160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-1) 2019-06-030000-00-00NoNoCurrent
71335-1238-27133512380230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-2) 2021-04-280000-00-00NoNoCurrent
71335-1238-37133512380315 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-3) 2022-06-290000-00-00NoNoCurrent
71335-1238-47133512380414 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-4) 2021-07-120000-00-00NoNoCurrent
71335-1238-57133512380510 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-5) 2021-08-300000-00-00NoNoCurrent
71335-1238-67133512380621 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-6) 2019-09-030000-00-00NoNoCurrent
71335-1238-77133512380790 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-7) 2022-06-290000-00-00NoNoCurrent
71335-1238-871335123808120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-8) 2022-06-290000-00-00NoNoCurrent
71335-1238-9713351238097 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-9) 2022-05-270000-00-00NoNoCurrent