FDA.reportPublic FDA data

NDC 80425-0146-01 - Duloxetine HCL 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
80425-0146
Requested NDC
80425-0146-01
Package NDCs from labels
80425-0146-2, 80425-0146-1, 80425-0146-3, 80425-0146-01
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
Duloxetine HCL 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
80425-0146-1Duloxetine HCLDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE309
80425-0146-2Duloxetine HCLDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE609
80425-0146-3Duloxetine HCLDR90 in 1 BOTTLECAPSULE, DELAYED RELEASE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0146DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_c4fa1d3b-f136-e14f-e053-2a95a90a6cfb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0146-1EA - Each80425-01463c472cb1-ec7d-4cd2-95f2-5fcd67ca178612023-06-06
80425-0146-2EA - Each80425-0146574073d7-581d-4d39-befa-18705d96487712023-06-06
80425-0146-3EA - Each80425-0146d2406371-2b40-4cdf-8c91-8c85a09eb3f012023-04-07

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 3 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEPD-Rx Pharmaceuticals, Inc.db85a82d-84f1-41c8-964b-ac94ae4d8e7b2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutionsfa5657a8-c6d9-474a-9d1a-b75b41b4327f2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596934
unii: 9044SC542W
DULOXETINEDULOXETINESolco Healthcare US, LLCa105a648-6a97-4151-b9de-d7eac90a8f792025-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutions7685a825-3c06-433d-ba98-4019c6ed25832025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596926
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutionse2352870-3582-4d92-8712-87ad8bdccb872025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutionse0381ead-d8bc-43fa-9f12-e0fefcaf7f3d2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEAphena Pharma Solutions - Tennessee, LLCc482d64a-73dd-4af2-9b3c-efff47e7395c2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596934
unii: 9044SC542W
duloxetineDULOXETINEQingdao BAHEAL Pharmaceutical Co., Ltd.e428429e-e1ea-40e1-870f-134533dc3aa12025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEQuallent Pharmaceuticals Health, LLC31362045-201f-45f3-99f2-a5e322a0c30b2025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 616402
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEAphena Pharma Solutions - Tennessee, LLC41c54fb7-03f8-2326-e063-6394a90a63522025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
DuloxetineDULOXETINEAphena Pharma Solutions - Tennessee, LLC4121bd3f-2d6d-3bdd-e063-6294a90a30882025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEQuallent Pharmaceuticals Health LLCb3b26383-9924-40f9-b4bb-43e30b70493e2025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596926
rxcui: 596930
rxcui: 616402
rxcui: 596934
unii: 9044SC542W
Duloxetine HydrochlorideDULOXETINE HYDROCHLORIDEMacleods Pharmaceuticals Limited177ce798-3924-416b-ba37-23dfa911a43b2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
duloxetineDULOXETINEInventia Healthcare Limited.eab90059-ea1c-46c1-884d-c15e7c562a012025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepackc52fc4ad-7bda-4824-8edf-117d3d8d6b3d2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEPreferred Phamaceuticals Inc.c5aac428-d929-4688-a9d5-4e9314aa62cc2025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEAjanta Pharma USA Inc.2dde979d-b6f8-41d1-96fb-325c75ea3a742025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
ndc (product): 27241-098
rxcui: 596926
rxcui: 596930
rxcui: 616402
rxcui: 596934
spl id: ae1a8c02-c1fc-474a-9411-cebecd99e339
spl set id: 2dde979d-b6f8-41d1-96fb-325c75ea3a74
unii: 9044SC542W
DuloxetineDULOXETINEBluePoint Laboratories1409fc2b-7252-472f-b719-e56141b36da22025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596926
rxcui: 596930
rxcui: 616402
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEAscend Laboratories, LLCe6477c41-97a2-45a7-94b5-487aa65199f62025-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
Duloxetine D/RDULOXETINE D/RDirect_Rx3ac53025-8a99-31de-e063-6294a90a53d22025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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