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 17 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb98d921a-2ee7-4770-ac21-d845b2dcc11c2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMP & L Development, LLC2596645a-b736-4d3c-82a0-00713f1b6fbd2022-12-15WarningsExact identifier
unii: QTG126297Q
DiclofenacDICLOFENAC SODIUMAltaire Pharmaceuticals Inc.5372866a-dab3-45c8-8c2a-755ca36c17912022-10-28Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAsclemed USA, Inc.9df599de-6412-a94e-e053-2995a90a17412022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.d4b81a74-6926-4715-bf90-aec026cff2b42022-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.b162d65d-b105-4a68-90bb-316b9686267b2022-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRite Aid Corporation1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f2022-08-23WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMProficient Rx LP67e384c6-8476-4aad-b967-241335538d562022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LPafce2de2-0c59-4191-bf79-782ca31e427d2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLProficient Rx LP33f7db0b-f049-4d2e-abf5-4db97222e1752022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions3a520306-fe3e-4830-963f-04b080db3abc2022-06-01Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
good sense arthritis painDICLOFENAC SODIUMProficient Rx LP67eacd91-8378-47e7-9bad-1e7b685aa9d42022-06-01WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP9eeb2aef-3eb1-4583-8180-d480deb3651c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP947c0c1f-3573-4f69-ab82-8b50c43e55862022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC047985ea-f768-4f9a-bfe3-0acf40a4781d2022-02-15WarningsExact identifier
unii: QTG126297Q
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSandoz Inc52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b2021-09-29Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.a57b897e-0cbe-4ac3-969f-b00357a0cfa82021-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Proficient Rx LP7e98952e-9b95-4296-9c23-c0ff4b82b2b72021-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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