FDA.reportPublic FDA data

NDC 80425-0273-01 - DICLOENAC SODIUM and MISOPROSTOL 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
80425-0273
Requested NDC
80425-0273-01
Package NDCs from labels
80425-0273-1, 80425-0273-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DICLOENAC SODIUM and MISOPROSTOL DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-02-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0273-1DICLOENAC SODIUM and MISOPROSTOLDR60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0273DICLOENAC SODIUM AND MISOPROSTOL DR (DICLOENAC SODIUM AND MISOPROSTOL) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20240224_f4d8c198-63e1-3109-e053-2995a90acad9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0273-1EA - Each80425-02733eacc955-b88d-467e-9b61-60fb0611f42812023-04-07

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 6 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
unii: QTG126297Q
MisoprostolMISOPROSTOLAvPAK2396e9c0-3742-69cf-e063-6394a90adb132026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions1e669fc2-69bf-4439-a336-a103e5b9cafe2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions8825dc2c-3497-455f-b5e1-2aa6672919572026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC47ce6fab-be1d-0076-e063-6294a90add632026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMQUALITY CHOICE (Chain Drug Marketing Association)98f94aa2-6bc2-4c07-81c8-63b2c262cf392026-01-06WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCc16e7e43-3869-9fef-e053-2995a90a1fdb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCf2b7ea75-738b-54a8-e053-2995a90a00d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC47a7a294-55bb-8d19-e063-6394a90a54402025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions40388047-7fbe-49bf-bed8-e5087bed4e032025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions4a88f136-f7c7-47d7-b85d-8a2f9f118f092025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
misoprostolMISOPROSTOLRedpharm Drug2fd197c6-05db-5011-e063-6294a90a585d2025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac sodiumDICLOFENAC SODIUMSafeway, Inc.196d8af7-739f-4d2c-8c4e-9d33e6d722ab2025-12-23WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug325213a3-241c-18d2-e063-6394a90a40f72025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLNivagen Pharmaceuticals, Inc.2acf46ac-8ba8-444d-b421-19d5ad49644c2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359105
rxcui: 857706
unii: QTG126297Q
unii: 0E43V0BB57

Reported adverse events (FAERS/openFDA)#

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