FDA.reportPublic FDA data

NDC 80425-0237-01 - Diclofenac Sodium

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
80425-0237
Requested NDC
80425-0237-01
Package NDCs from labels
80425-0237-1, 80425-0237-01
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 - 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
80425-0237-1Diclofenac Sodium150 mL in 1 BOTTLESOLUTION1504
80425-0237-1Diclofenac Sodium1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0237DICLOFENAC SODIUM SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, 2 package rows20250102_f1896c84-b18a-d49d-e053-2995a90aaab3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0237-1ML - Milliliter80425-0237e028fbd8-98bc-4f4a-97fa-fd08d74407b312023-03-13

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 14 of 18 · 357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2bebda5e-227e-4a49-80e3-191cfc8052952024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions203f96bb-ae63-475c-b7a6-03c0dbc435972024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack12cce748-a7de-4b1e-9603-b5c2ce12d5312024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2b7462e6-62dc-4b08-9fbf-5858e356a7a82024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMEXELAN PHARMACEUTICALS INC.be25c19e-cbea-4f87-a581-9f0d350e5adf2024-08-02WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b82024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.005299ac-b6de-511f-e063-6294a90a29e02024-07-29WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.4b44ac98-225c-1739-e054-00144ff88e882024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.abacf60f-0410-e6da-e053-2995a90a413c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC78873f83-cea9-44d4-8ad4-8cb9257e5c7f2024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206116
ndc (product): 65162-911
rxcui: 857700
spl id: 6feda2fe-70b6-4dbe-a969-97857501dd1f
spl set id: 78873f83-cea9-44d4-8ad4-8cb9257e5c7f
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1d4d6370-2b45-fa6d-e063-6294a90a4a672024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%NuCare Pharmaceuticals,Inc.0326ea5b-3e1a-dee2-e063-6294a90a13b82024-07-09WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC81e964ff-6622-4054-bf01-6ed6eef6778f2024-07-06WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP898558e7-17f8-40cd-9dfc-67ddd64a5a422024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMKROGER COMPANY15e59aac-a642-91e4-e063-6294a90a11752024-06-28WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1be247b8-dafd-ddf9-e063-6294a90aa9e12024-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Curist Arthritis ReliefDICLOFENAC SODIUMLittle Pharma, Inc.e638a98e-e6d7-36ed-e053-2995a90af2ca2024-06-21WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.8721da56-0f8a-5903-e053-2991aa0a61b52024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.8bda6135-c957-6b4e-e053-2995a90a0cb52024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions5d74488c-e092-415d-b19b-05318380d9b12024-06-10Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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