Diclofenac Sodium

Product NDC
85766-010
11-digit product format
857660010
Labeler code
85766
Product ID
85766-010_49eec2b4-4e7e-065f-e063-6394a90af76f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA077863
Marketing category
ANDA
Marketing start
2008-08-19
Substance
DICLOFENAC SODIUM
Active strength
75 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
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855926Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9ec5462-939a-4022-8946-5d81869a6277Available on FDA.report

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
85766-010-01Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1004
85766-010-14Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE144
85766-010-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304
85766-010-60Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE604
85766-010-90Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE904

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
ndc (product): 85766-010
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNe9ec5462-939a-4022-8946-5d81869a62774
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDe9ec5462-939a-4022-8946-5d81869a62774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-010-0185766001001100 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-01) 2025-06-18NoNoCurrent
85766-010-148576600101414 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-14) 2025-09-24NoNoCurrent
85766-010-308576600103030 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-30) 2025-06-18NoNoCurrent
85766-010-608576600106060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85766-010-60) 2025-06-18NoNoCurrent
85766-010-908576600109090 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-90) 2025-06-18NoNoCurrent