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 1 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEHAWAII REPACK, INCb32a39d8-5f1a-4e44-bc46-b65925bde7532026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEHAWAII REPACK, INC.79bfd6be-a1ff-4786-b4e2-abbd0a3e39322026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEREMEDYREPACK INC.ed164dbb-e713-42d1-a78e-31145578b9f82026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.00628e5e-4c5b-2573-e063-6294a90a0e3b2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINENorthwind Health Company, LLCc194a7b0-1e7e-a32b-e053-2995a90a7dbd2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINEREMEDYREPACK INC.461d769c-b787-4bc7-b4a6-7a5f33ae9d452026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINEGolden State Medical Supply, Inc.569582d5-cb6d-735e-e063-6394a90abfb62026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepack79e1a9b1-e084-48b6-a252-97bbd2f55a792026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINESt. Mary's Medical Park Pharmacy9221f3e5-17b8-ea74-e053-2a95a90ad1a82026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINEREMEDYREPACK INC.ac903bda-76af-4aba-9c8a-ebf7066e05ee2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINESt. Mary's Medical Park Pharmacy9221aea1-8de1-b94e-e053-2a95a90a1eae2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEREMEDYREPACK INC.c66fb2ee-f64a-4d28-a692-e8dc7b61fbc92026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINEANI Pharmaceuticals, Inc.fb37745f-fb40-4f7f-8143-ea1874c38e1b2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEREMEDYREPACK INC.1d3a45f3-3854-4d0c-9241-770aa24063fd2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEYaopharma Co., Ltd.90224073-178d-7ec5-e053-2995a90a20fc2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEREMEDYREPACK INC.b149641a-03e6-4fee-91f3-7ba8e01196bd2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINESt. Mary's Medical Park Pharmacy39fa4247-e864-f653-e063-6394a90ac98d2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEREMEDYREPACK INC.b9f20917-9529-4c62-bafe-baae7f8d6c772026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINEPreferred Pharmaceuticals Inc.22a2ad76-0841-46fe-85e1-101afd9249392026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DuloxetineDULOXETINELupin Pharmaceuticals, Inc.829a4f51-c882-4b64-81f3-abfb03a52ebe2026-05-20Boxed 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.