FDA.reportPublic FDA data

NDC 80425-0197-03 - 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
80425-0197
Requested NDC
80425-0197-03
Package NDCs from labels
80425-0197-2, 80425-0197-3, 80425-0197-03
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
80425-0197-2Diclofenac SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE606
80425-0197-3Diclofenac SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0197DICLOFENAC SODIUM DR (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_ec06cca5-3436-10c8-e053-2995a90a4aeb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0197-2EA - Each80425-0197104a4655-ccc2-4206-a045-0825a0c23e3b12023-03-13
80425-0197-3EA - Each80425-01976b7ab87e-1dda-4e44-8a92-79ac2ae494db12023-03-13

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 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.5a852412-69af-6502-e063-6294a90a07482026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
DiclofenacDICLOFENAC SODIUMYYBA CORP533653e8-93d5-9080-e063-6394a90a165b2026-09-01WarningsExact identifier
unii: QTG126297Q
Diclofenac sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLMylan Pharmaceuticals Inc.a7701e8c-4e16-4165-8b83-de2c08d5ded32026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC5990259d-2f90-20d3-e063-6394a90a3d232026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
AMAZON BASIC CARE ARTHRITIS PAINDICLOFENAC SODIUMAmazon.com Services LLC113e2f87-c408-3e44-e063-6394a90a0a7f2026-08-20WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC4dde6e36-7540-1cc3-e063-6294a90a39412026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSportpharm LLCe9ec5462-939a-4022-8946-5d81869a62772026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)2a7019e9-e20f-4897-9b8e-942a7f2b34f62026-08-12WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.226da8a2-807d-4784-8d33-b434f3951a522026-08-12WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.681b6b25-4a28-44f2-8042-d5e01a5021162026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.57c83158-f072-6fa2-e063-6394a90aee2c2026-07-29WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.ddd2278b-70be-41ca-8a84-e3fe0f1a15612026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCVS Pharmacy591cc2ed-e667-4779-a426-8a2e6f8735732026-07-22WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMAurobindo Pharma Limitedd9b6f1d0-1710-46fb-8ea4-80b3ca60a5752026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMHAWAII REPACK, INCea113a58-c7ed-4768-9777-93d9b166dfbe2026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%Sportpharm LLC391d9d0b-74b7-4359-aea0-d3bb8c8d3cd12026-07-10WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packaging63c00b50-06d3-4659-81cf-be4516429e812026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.6e6a6f98-5517-4f67-9a6a-71019ba2d7732026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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