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 5 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMRugby Laboratories95f3c70c-eded-4d24-b9b0-cfa0b7902d6e2026-02-10WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Sportpharm LLCa133d18e-981d-43b7-bef1-7869f7c7d9a72026-02-09WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMREMEDYREPACK INC.6aab6c1f-9b02-4101-b7c8-ab7a557043202026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLC11e88ced-cdcf-4101-9297-c4c3dde9d0892026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMSportpharm LLC99f1e69e-02cf-49c2-83af-3cccbbea42152026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions0cefb675-c54e-44eb-b35c-38354b77eddd2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions74011b00-7e2e-40a7-ab30-c05a205598142026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMUmedica Laboratories USA Inc.0e5c6669-390f-4c32-b9b8-13ed3c5174622026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMFamily Dollar (FAMILY WELLNESS)03ddf347-a3a3-4313-87d1-a246c1d4e0b42026-01-29WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBausch & Lomb Incorporated39dfffb0-612a-48f3-8db5-1a59899b91e92026-01-27Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMIngenus Pharmaceuticals, LLC1a237198-ca24-4159-b570-b5a23c8e91b02026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutionsf92576d7-3ad9-43a3-8b10-3a29fbf712a42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutions6c57e330-ebbe-4165-84a8-4844b2f0097e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMPublix Super Markets Incbae07276-c800-468e-a201-e6268846fff32026-01-15WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUM TOPICALDICLOFENAC SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED181e32ab-5ec0-4be4-bad0-b6bbafc08f852026-01-15WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSportpharm LLC929f71ab-f0c8-4331-800d-ed4a172e647e2026-01-14WarningsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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