FDA.reportPublic FDA data

NDC 80425-0189-01 - Diclofenac Sodium DR

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0189
Requested NDC
80425-0189-01
Package NDCs from labels
80425-0189-1, 80425-0189-2, 80425-0189-3, 80425-0189-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0189-1Diclofenac SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE606
80425-0189-2Diclofenac SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE306
80425-0189-3Diclofenac SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0189DICLOFENAC SODIUM DR (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20250101_d424ab84-2aaa-38a9-e053-2a95a90adde9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0189-1EA - Each80425-01891cc1ed3c-bfe6-449b-8220-36962f0168af12023-03-13
80425-0189-2EA - Each80425-0189b2b4c1f7-3353-4bcb-947e-56e9782f23ed12023-04-07
80425-0189-3EA - Each80425-01890d40ec80-d802-40a2-b8c1-d0f7c388ca5912023-04-07

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 9 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.39e67a90-df3e-ad30-e063-6394a90a7a822025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.f9a0c654-5f77-430f-b921-295eb776cbcd2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvagen Pharma Ltdac2b4060-a5da-4ddf-a734-2ff58a1f98c92025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.aa1e1ed3-0444-4bf5-a0ee-5d21a7fca3912025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMChain Drug Consortium, LLC8879a2ed-6c66-4489-8adc-9f160241cc7d2025-06-25WarningsExact identifier
unii: QTG126297Q
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Companyc30353da-acd6-474f-8a64-abd078bf4f852025-06-11WarningsExact identifier
unii: QTG126297Q
members mark arthritis pain relieverDICLOFENAC SODIUMSam's West Inc44533b5b-73ce-4853-9eda-506426cb9b822025-06-09WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLBryant Ranch Prepack7225385c-501c-4e90-8948-8617d583108c2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.363764a0-e0a8-3e3f-e063-6294a90ad6722025-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC45321aec-368d-4ca4-a0c5-2ce56fae74b22025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.40879600-ba6c-43a8-aa5d-d0d41503d5932025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
ndc (product): 61442-103
rxcui: 855926
rxcui: 855906
spl id: 350d8fde-4096-17eb-e063-6394a90a9984
spl set id: 40879600-ba6c-43a8-aa5d-d0d41503d593
unii: QTG126297Q
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATESTRAND HEALTH GROUP2d92d378-2e9c-f9d5-e063-6294a90ac7152025-05-21WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMAurobindo Pharma Limited3487033c-7c62-4034-8718-73a7c49b26a02025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.87d5a720-f154-4c4b-b2d4-0ae58455dda02025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
DiclonaLIDOCAINE 4.5%, DICLOFENAC 1%Advanced Rx of Tennessee, LLC34685ef2-0015-8941-e063-6294a90ad0f72025-05-05Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.03abebd6-426a-9d05-3dff-1964773894302025-05-05WarningsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMBluePoint Laboratories896e3f7d-88e6-4563-b879-a2757d19fd622025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMAdvagen Pharma Ltd72419a68-4c9d-44e0-9b43-922440e2c8d72025-04-30Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.