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 5 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINENuCare Pharmaceuticals, Inc.2c288791-2d8f-84bb-e063-6294a90a7e1e2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINENuCare Pharmaceuticals, Inc.2b61c261-d7f2-4f9d-e063-6294a90acc242025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINENCS HealthCare of KY, LLC dba Vangard Labs54749431-430e-4532-97f7-4b1cd8dd252e2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx of Tennessee, LLCaf6f8abd-19ec-69e4-e053-2a95a90ab69e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx of Tennessee, LLCafd59273-75cb-5f33-e053-2995a90ab25f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx of Tennessee, LLCb33cbab8-1962-cb66-e053-2a95a90a4ae72024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc4fa1d3b-f136-e14f-e053-2a95a90a6cfb2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
ndc (package): 80425-0146-1
ndc (package): 80425-0146-3
ndc (package): 80425-0146-2
ndc (product): 80425-0146
ndc11 (package): 80425014601
rxcui: 596930
spl id: 2a999573-1035-813a-e063-6294a90a49b1
spl set id: c4fa1d3b-f136-e14f-e053-2a95a90a6cfb
unii: 9044SC542W
Duloxetine DRDULOXETINEAdvanced Rx Pharmacy of Tennessee, LLCb70035d4-5a3f-c5b5-e053-2995a90acac12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596934
unii: 9044SC542W
Duloxetine DRDULOXETINEAdvanced Rx Pharmacy of Tennessee, LLCf8c0bc80-b34e-daa8-e053-6394a90a05c22024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596926
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df61b895-c358-827b-e053-2995a90a9b602024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepack39e293d5-c575-49db-8389-7ac2269c49bb2024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEZydus Lifesciences Limitedf36b414e-ace4-4f04-a80f-75bb25db430d2024-11-28Exact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEAurobindo Pharma Limited3adfceb3-5f89-4bcf-b874-e3cb572a98b62024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEAdvanced Rx of Tennessee, LLC19afed24-39ad-daf1-e063-6394a90ad7372024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEProficient Rx LP3dec1805-9a95-462e-8784-303004d500b12024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
DuloxetineDULOXETINECamber Pharmaceuticals, Inc.b14feecc-04c6-4b2d-ba55-2e1dbef6b0d72024-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack41876761-9d5b-4190-a200-6a822c54582e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack0c82422a-d493-4dda-8626-0d9baa25db8c2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepackb19ba26f-4711-443e-83cf-5af7bb43a0a02024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepack3fbdcc34-6166-4843-839c-33fed718ffb22024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596930
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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