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 2 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.6e6a6f98-5517-4f67-9a6a-71019ba2d7732026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.71a823c4-9c88-474d-b525-276f9e7808aa2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.09643e65-f301-4891-96f4-d78bf3621e232026-07-02WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.30c7e4fd-30af-4d28-a6ef-7386ff83cfb82026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packagingdbb1489d-b690-4e53-905d-7fb07ad263b32026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
misoprostolMISOPROSTOLBryant Ranch Prepackc842c35f-6a64-4ecc-95a1-41b6d056047e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
ARTHRITIS PAIN RELIEFDICLOFENAC SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED84978746-4ab5-456d-af63-5c86ab0a05f52026-06-29WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.10991fe6-fafd-49af-9684-83b447c19c672026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MisoprostolMISOPROSTOLAmerican Health Packaging9462d969-d3e5-4e7f-b556-bd647ab28c422026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac sodiumDICLOFENAC SODIUMREMEDYREPACK INC.6980431d-4a2b-41e9-ae86-d46b4513f04b2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMASCLEMED USA INC.53e8ad44-ff67-d3bb-e063-6394a90a524d2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MisoprostolMISOPROSTOLGenBioPro, Inc.21e20753-4a67-ce4e-e063-6394a90aa5982026-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac SodiumDICLOFENAC SODIUM TOPICALREMEDYREPACK INC.cc8c3125-ee43-40bb-8500-339efa901b8c2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
CytotecMISOPROSTOLPfizer Laboratories Div Pfizer Inc4ab12da7-5731-4e06-bf1c-bc3f2e711f122026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac SodiumDICLOFENAC SODIUMSt. Mary's Medical Park Pharmacy5f4b69de-8ddd-26c5-e053-2a91aa0ab3262026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMGolden State Medical Supply, Inc.c1d87003-f54b-4381-9e11-1c39ea2d9eb32026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000081b43f9-f594-4b1e-8564-7dbbea6fa5bd2026-05-26WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6865a5cf-3263-44b5-96d9-7a7a4c6e1c052026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359105
unii: QTG126297Q
unii: 0E43V0BB57
MisoprostolMISOPROSTOLBryant Ranch Prepackc4668066-3d67-487d-9071-f1e504f664992026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1eb7a7bb-c524-4168-8ade-4601dc11533b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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