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 5 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMUmedica Laboratories USA Inc.0e5c6669-390f-4c32-b9b8-13ed3c5174622026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
rxcui: 855664
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMFamily Dollar (FAMILY WELLNESS)03ddf347-a3a3-4313-87d1-a246c1d4e0b42026-01-29WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
rxcui: 855664
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBausch & Lomb Incorporated39dfffb0-612a-48f3-8db5-1a59899b91e92026-01-27Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMIngenus Pharmaceuticals, LLC1a237198-ca24-4159-b570-b5a23c8e91b02026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090066
rxcui: 855906
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutionsf92576d7-3ad9-43a3-8b10-3a29fbf712a42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutions6c57e330-ebbe-4165-84a8-4844b2f0097e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMPublix Super Markets Incbae07276-c800-468e-a201-e6268846fff32026-01-15WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
DICLOFENAC SODIUM TOPICALDICLOFENAC SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED181e32ab-5ec0-4be4-bad0-b6bbafc08f852026-01-15WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSportpharm LLC929f71ab-f0c8-4331-800d-ed4a172e647e2026-01-14WarningsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMSportpharm LLCac631742-119f-408a-8b36-b041bab743e22026-01-14WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAvKARE19b4ff5c-adb7-a0d0-7ef2-4ae05047fd942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAvKARE0416ce03-c345-9d9e-e063-6294a90ad9402026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%Asclemed USA, Inc.6952a221-17fd-4592-8edc-ff36997435332026-01-13WarningsExact identifier
unii: QTG126297Q
Aspercreme ArthritisDICLOFENAC SODIUMChattem, Inc.81f78685-c416-48b5-8840-eef03a66bc282026-01-12WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.14c1b1a1-bc06-4722-9612-e88ae52272bc2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions1e669fc2-69bf-4439-a336-a103e5b9cafe2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090066
rxcui: 855926
rxcui: 855906
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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