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 12 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCec06cca5-3436-10c8-e053-2995a90a4aeb2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium ERDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCecaa39b8-067c-80d7-e053-2a95a90a73542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7267-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1896c84-b18a-d49d-e053-2995a90aaab32024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7264-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf3d27ae6-1259-5375-e053-2995a90a572d2024-12-31WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf187ae44-71be-a682-e053-2995a90a64262024-12-31Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAdvanced Rx Pharmacy of Tennessee, LLCfc100cb2-16d9-f67d-e053-6294a90a0f2e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAdvanced Rx Pharmacy of Tennessee, LLCfc0e6a51-bec3-f7ee-e053-6394a90ada9a2024-12-31Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCfc0e1950-d76f-75bc-e053-6294a90a8c122024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCaf8a1392-67e8-8201-e053-2a95a90a0fce2024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMQuality Care Products, LLC3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products, LLC12e1f808-9f24-4f6d-b5bc-12ce0059ab7a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLCf18a4691-93a1-01e6-e053-2995a90a00692024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
InflammacinDICLOFENAC SODIUM, CAPSAICINPureTek Corporation91d25301-fac9-41f0-8a4e-e22d449263472024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, LLC.26e44aa5-cfcd-f10b-e063-6394a90a4dcf2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENACScholl's Wellness Company8dcbce69-945b-4913-a279-ee10871f65802024-11-14WarningsExact identifier
unii: QTG126297Q
SalonpasDICLOFENAC SODIUMHisamitsu America, Inc.f439445d-046e-4220-a4a7-13d750ee09492024-11-14WarningsExact identifier
unii: QTG126297Q
MOTRIN ARTHRITIS PAINDICLOFENAC SODIUMKenvue Brands LLCdb5b4288-13ec-826b-e053-2995a90a275e2024-11-08WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepackbf372e32-0902-447f-9673-00a3fcf0064c2024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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