Diclofenac Sodium

Product NDC
85509-1201
11-digit product format
855091201
Labeler code
85509
Product ID
85509-1201_47ce6fbc-b69b-f4de-e063-6294a90ae435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PHOENIX RX 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
47ce6fab-be1d-0076-e063-6294a90add63Available 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
85509-1201-3Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
85509-1201-6Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE601
85509-1201-9Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1201-3EA - Each85509-1201c370490c-ad89-4f40-afed-a970f2fc692212026-02-05
85509-1201-6EA - Each85509-1201ad58dcfb-8813-4b74-b407-c951b6c0f38112026-02-05
85509-1201-9EA - Each85509-12013830b95b-aaee-44ae-b0b4-489b53e890d412026-02-05

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
ndc (product): 85509-1201
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 TabletPSN47ce6fab-be1d-0076-e063-6294a90add631
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD47ce6fab-be1d-0076-e063-6294a90add631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1201-38550912010330 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-3) 2026-01-07NoNoCurrent
85509-1201-68550912010660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1201-6) 2026-01-07NoNoCurrent
85509-1201-98550912010990 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-9) 2026-01-07NoNoCurrent