FDA.reportPublic FDA data

NDC 80425-0014-01 - 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
80425-0014
Requested NDC
80425-0014-01
Package NDCs from labels
80425-0014-2, 80425-0014-1, 80425-0014-01
Manufacturer
Advanced Rx 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 of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0014-1Duloxetine HCLDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
80425-0014-2Duloxetine HCLDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0014DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_afd59273-75cb-5f33-e053-2995a90ab25f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0014-1EA - Each80425-001401f13271-03ce-4cfd-8bf4-e972ec84ee7d12023-04-07
80425-0014-2EA - Each80425-0014a797dd86-ceea-406e-9882-5e5257c5e90212023-04-07

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 · 128 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINENuCare Pharmaceuticals, Inc.2b61c261-d7f2-4f9d-e063-6294a90acc242025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINENCS HealthCare of KY, LLC dba Vangard Labs54749431-430e-4532-97f7-4b1cd8dd252e2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
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
application number: ANDA090778
ndc (package): 80425-0014-2
ndc (package): 80425-0014-1
ndc (product): 80425-0014
ndc11 (package): 80425001401
rxcui: 596930
spl id: 2a985779-9478-6d0e-e063-6294a90aa2a7
spl set id: afd59273-75cb-5f33-e053-2995a90ab25f
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
rxcui: 596930
unii: 9044SC542W
Duloxetine DRDULOXETINEAdvanced Rx Pharmacy of Tennessee, LLCb70035d4-5a3f-c5b5-e053-2995a90acac12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Duloxetine DRDULOXETINEAdvanced Rx Pharmacy of Tennessee, LLCf8c0bc80-b34e-daa8-e053-6394a90a05c22024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df61b895-c358-827b-e053-2995a90a9b602024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
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: 596930
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEAurobindo Pharma Limited3adfceb3-5f89-4bcf-b874-e3cb572a98b62024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090778
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEAdvanced Rx of Tennessee, LLC19afed24-39ad-daf1-e063-6394a90ad7372024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEProficient Rx LP3dec1805-9a95-462e-8784-303004d500b12024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINECamber Pharmaceuticals, Inc.b14feecc-04c6-4b2d-ba55-2e1dbef6b0d72024-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
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
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepackb19ba26f-4711-443e-83cf-5af7bb43a0a02024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepack3fbdcc34-6166-4843-839c-33fed718ffb22024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackca376622-d32c-4e6e-8af4-8e24a8d20d832024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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