FDA.reportPublic FDA data

NDC 80425-0119-01 - Duloxetine 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
80425-0119
Requested NDC
80425-0119-01
Package NDCs from labels
80425-0119-1, 80425-0119-2, 80425-0119-3, 80425-0119-01
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 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
80425-0119-1DuloxetineDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
80425-0119-2DuloxetineDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE608
80425-0119-3DuloxetineDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0119DULOXETINE DR (DULOXETINE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_b70035d4-5a3f-c5b5-e053-2995a90acac1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0119-1EA - Each80425-0119d3634664-507c-4d01-bf7a-4c68186a753812023-04-07
80425-0119-2EA - Each80425-01191cfa181c-4e3e-4641-896f-535e5f43d67012023-04-07
80425-0119-3EA - Each80425-0119daa7166e-9c7a-4811-9615-9e11ce198d7312023-06-06

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEProficient Rx LPe36a6919-568a-4d4a-9920-7a7fe4f3441c2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEProficient Rx LP39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb72022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208706
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINESun Pharmaceutical Industries, Inc.f16beb64-5878-486a-82ee-8e83e728f26c2021-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEProficient Rx LP51c342c9-b9c6-467d-8fea-b73d72e3febc2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEProficient Rx LPc34f6115-f447-450f-8c83-58f3c51a76c92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEProficient Rx LPd0a48dfd-af34-470b-9e1f-7678203e9ae52020-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb102b8e6-d58f-419c-bb35-720bafa132942020-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
unii: 9044SC542W
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP407b62b9-5b32-4bac-a2b0-7df4992792482019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdb686a0a-9b2a-4017-8bd1-b981da47c2f32019-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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