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 6 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions8825dc2c-3497-455f-b5e1-2aa6672919572026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC47ce6fab-be1d-0076-e063-6294a90add632026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMQUALITY CHOICE (Chain Drug Marketing Association)98f94aa2-6bc2-4c07-81c8-63b2c262cf392026-01-06WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCc16e7e43-3869-9fef-e053-2995a90a1fdb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCf2b7ea75-738b-54a8-e053-2995a90a00d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC47a7a294-55bb-8d19-e063-6394a90a54402025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions40388047-7fbe-49bf-bed8-e5087bed4e032025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions4a88f136-f7c7-47d7-b85d-8a2f9f118f092025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMSafeway, Inc.196d8af7-739f-4d2c-8c4e-9d33e6d722ab2025-12-23WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug325213a3-241c-18d2-e063-6394a90a40f72025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLNivagen Pharmaceuticals, Inc.2acf46ac-8ba8-444d-b421-19d5ad49644c2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions58063c26-86fe-4f03-97ef-51706e5f40542025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug37362eb4-db16-f4ad-e063-6394a90a42aa2025-12-13WarningsExact identifier
unii: QTG126297Q
UP AND UP ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTarget Corporation3a9b32af-a3cd-496b-9698-0421443e03852025-12-08WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%SOLA Pharmaceuticalsbdbe3f24-3015-1f32-e053-2995a90aa6652025-12-08WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALSOLA Pharmaceuticalsc3f33952-44a8-71b2-e053-2a95a90abda22025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC4539e9e7-5d82-3b36-e063-6394a90a13962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Aleve Arthritis Pain GelDICLOFENAC SODIUMBayer HealthCare LLCbad675d1-1204-0136-e053-2995a90a994e2025-12-04WarningsExact identifier
unii: QTG126297Q
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATEASCLEMED USA INC.263f64d5-da3e-43cc-a651-2136f3b1f2ea2025-12-02WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALProficient Rx LP140a2c64-4996-4da3-b10f-1b8235ebde9d2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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