Diclofenac Sodium

Product NDC
80425-0102
11-digit product format
804250102
Labeler code
80425
Product ID
80425-0102_2a9968c3-c1b8-9ce1-e063-6294a90a8051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090066
Marketing category
ANDA
Marketing start
2010-12-31
Substance
DICLOFENAC SODIUM
Active strength
50 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

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
A090066-001DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01
A090066-002DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090066-001AB
A090066-002AB

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 UTC2026-02A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2010-12-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2010-12-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01782e0a99824c…

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 UTC2026-02A090066-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090066-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090066-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090066-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090066-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090066-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090066-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090066-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090066-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090066-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090066-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090066-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090066-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090066-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090066-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090066-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090066-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090066-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 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
855906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3dbd981-453c-645f-e053-2a95a90aec3cAvailable 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
80425-0102-2Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE607
80425-0102-3Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0102-2EA - Each80425-01022cb0fb85-5d9d-4f5c-b763-1f9e7ee8ee6012023-03-13
80425-0102-3EA - Each80425-0102cd495b9d-ae89-455a-bad3-936f2950d31512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0102DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_b3dbd981-453c-645f-e053-2a95a90aec3c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packaging63c00b50-06d3-4659-81cf-be4516429e812026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions1e669fc2-69bf-4439-a336-a103e5b9cafe2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions8825dc2c-3497-455f-b5e1-2aa6672919572026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMBluePoint Laboratoriesfeb1541a-de83-47dd-be03-c433765273182025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack4e97c685-628a-4b83-ba9e-2d3caf65542b2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepackaf480e78-ff65-4709-af26-c430aefb77d62025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLCb3dbd981-453c-645f-e053-2a95a90aec3c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 80425-0102
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP9eeb2aef-3eb1-4583-8180-d480deb3651c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNb3dbd981-453c-645f-e053-2a95a90aec3c7
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDb3dbd981-453c-645f-e053-2a95a90aec3c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0102-28042501020260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0102-2) 2010-12-310000-00-00NoNoCurrent
80425-0102-38042501020390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0102-3) 2010-12-310000-00-00NoNoCurrent