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 15 of 18 · 351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf104f8fb-066f-4bbf-8894-3b3ed1b8266d2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodium and Misoprostol DRDICLOFENAC SODIUM AND MISOPROSTOLAdvanced Rx Pharmacy of Tennessee, LLC1213d3eb-9870-f144-e063-6394a90a60882024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOENAC SODIUM and MISOPROSTOL DRDICLOENAC SODIUM AND MISOPROSTOLAdvanced Rx Pharmacy of Tennessee, LLCf4d8c198-63e1-3109-e053-2995a90acad92024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackdf5bb0e7-a3a9-4650-aae7-9a11ce615d5d2024-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd17bd62a8-b697-48cc-b988-aac3c19c6dc52024-01-22WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack7c3d8d33-8849-44df-bb57-57d32b96a0e42024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackbced0ef0-085a-40db-9678-2bc6eb77d4562024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac sodiumDICLOFENACAmneal Pharmaceuticals NY LLC1084e0c3-6d75-4090-84dc-02a18e0299b92023-12-29WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,A-S Medication Solutions828b5de2-77a7-4893-ab47-dffc8ea736932023-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions50efc183-dd3e-4eb7-ba5c-c42fd76e0b652023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMProficient Rx LPf19bf286-f4dd-4491-90c3-9f87130719032023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMCVS Pharmacye9ccaf95-582b-4d4d-938f-7577eaa8dffb2023-11-27WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepacke6a1ff58-a541-46f8-9663-eed53b7cf3922023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions51756947-e802-4b4d-883e-fd6f22e9a7252023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions9df87100-acf5-4b46-93b4-067b470136bd2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC4808015d-cfee-4f4d-a84b-82099f0b48682023-10-04WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions0379c918-1717-40ab-81cc-268116950fd52023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.6a9c3cea-7b46-427d-99af-90c1f290b1902023-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
equaline arthritis pain relievingDICLOFENAC SODIUMUnited Natural Foods, Inc. dba UNFI748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d02023-08-23WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC2a599579-b2b0-4423-8e30-fe04bf8158702023-08-11WarningsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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