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 16 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis Pain RelieverDICLOFENAC SODIUMAmerisourceBergen (Good Neighbor Pharmacy) 4612230e1f589-b322-48b7-9a97-502afe2a1baa2023-08-09WarningsExact identifier
unii: QTG126297Q
equate arthritis painDICLOFENAC SODIUMWal-Mart Stores Inc5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b2023-07-27WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepack16853c78-493a-4b8b-87b9-97dc927e1c8e2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
CareOne arthritis pain reliefDICLOFENAC SODIUMAmerican Sales Company69615972-b593-44fb-ae49-9441d872d84a2023-06-08WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACProficient Rx LPf4da38af-c5bd-4d4a-a6f3-c2933f2238092023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACBryant Ranch Prepacke5f8284a-1aa9-4a36-a6ad-fa153c613f342023-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DG health arthritis painDICLOFENAC SODIUMDolgencorp Ince7f93d8f-df2b-4005-b58d-c6f10ae0e0f32023-05-24WarningsExact identifier
unii: QTG126297Q
arthritis pain relieverDICLOFENAC SODIUMPublix Super Markets Inc445de976-9a28-4e97-929f-c77aeb21c1fa2023-05-15WarningsExact identifier
unii: QTG126297Q
arthritis pain relievingDICLOFENAC SODIUMMeijer Distribution Incd46a4841-2f86-4e0e-ac79-9b1444ed4f792023-05-15WarningsExact identifier
unii: QTG126297Q
topcare athritis pain relieverDICLOFENAC SODIUMTopco Associates LLCd3e9416d-e13b-4cc7-a663-6df3534b8dbe2023-05-10WarningsExact identifier
unii: QTG126297Q
good sense arthritis painDICLOFENAC SODIUML. Perrigo Company7b32b9e4-6502-4fa3-808f-3bef9525b6a12023-05-10WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACA-S Medication Solutions58178f0d-3960-48e3-91ba-150f691be2412023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Crcle Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL 1%Innovus Pharmaceuticals Inc.b373c202-5795-418f-989c-1ec5837145af2023-03-24WarningsExact identifier
unii: QTG126297Q
arthritis pain relieverDICLOFENAC SODIUMH E Be8fe4a89-586d-461c-b242-b68e38a508b42023-03-09WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products LLC94422b85-28ed-477f-853a-71d1d6cf17d52023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP73a46413-ecbc-4453-814d-bec955b375d22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPb41335b6-859f-4568-84d2-0d0408415a4e2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCostco Wholesale141b6693-6d6c-45c6-9b82-ee1afcfca12a2023-01-27WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Proficient Rx LPb4694451-a13d-484e-92c4-c03a6fcbb5112023-01-01WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALProficient Rx LP90b25b9b-3930-48af-b139-d24f2fccfcdc2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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