FDA.reportPublic FDA data

NDC 80425-0102-03 - Diclofenac Sodium

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
80425-0102
Requested NDC
80425-0102-03
Package NDCs from labels
80425-0102-3, 80425-0102-2, 80425-0102-03
Manufacturer
Advanced Rx 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 - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 3 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepackb28e4a68-f396-4c1a-ba38-6a972906b4d02026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALASCLEMED USA INC.fd94964b-167b-41b7-a612-8febe9ae05112026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.96f8c42c-db34-43b0-a891-33dd8e39e74f2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e947653c-6789-4c15-82c9-4b1402f6d6ac2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.ed1b5ec7-2812-4a81-90d1-953baa0b0ec82026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAurolife Pharma LLCdfb7afdf-5c05-4487-9044-936e151e5ba62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.5d0a4b41-afbf-45e7-bb1c-587d72314ee02026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.15b280a1-4964-4636-833b-3db44044d2892026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACPreferred Pharmaceuticals Inc.937e9ba5-cdad-4e72-a77a-bad699e1b2362026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals, Inc.4a3549e0-1e2d-42bf-b82c-1e62837ba2e42026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e042e64c-5f18-4483-bcbd-dfd9b08a81cf2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Preferred Pharmaceuticals, Inc.aee20924-79ab-400e-b9b6-4189789146542026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
arthritis pain relievingDICLOFENAC SODIUMWalgreen Company0da5d1d0-d8a4-4509-a098-e9c36d2824742026-03-31WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMREMEDYREPACK INC.d349d286-b462-4f8f-aa39-6173653175d62026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090066
rxcui: 855926
rxcui: 855906
rxcui: 855664
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMST. MARY'S MEDICAL PARK PHARMACY4ddd7e34-e5f4-8f05-e063-6294a90a70aa2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLSportpharm LLC0d6509a1-7af8-473b-8951-c194392743792026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAvKARE3643ab1b-9f8f-b2f4-e02d-950d0a02e5872026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.663a3dbc-a631-4046-8852-ec619c41c81d2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium Topical SolutionDICLOFENAC SODIUM TOPICAL SOLUTIONDirect_Rx223f0fb4-2006-c2dd-e063-6394a90a563a2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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