FDA.reportPublic FDA data

NDC 80425-0086-01 - 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
80425-0086
Requested NDC
80425-0086-01
Package NDCs from labels
80425-0086-2, 80425-0086-1, 80425-0086-01
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
80425-0086-1Duloxetine HCLDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS308
80425-0086-2Duloxetine HCLDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0086DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE PELLETS [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 2 package rows20250101_b33cbab8-1962-cb66-e053-2a95a90a4ae7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0086-1EA - Each80425-0086102f4941-252e-4913-9548-2e4635b2794d12023-04-07
80425-0086-2EA - Each80425-00868b2a3537-4838-4173-a964-1e4ee15359c012023-04-07

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 6 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackca376622-d32c-4e6e-8af4-8e24a8d20d832024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepack4673ccdd-c86c-4ddc-b462-941897ecfd222024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090776
rxcui: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEA-S Medication Solutionsbe33f3cb-6fd1-4377-816e-84bd49370e9e2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutions2be9e5fb-011e-424b-b504-df2a28b5271d2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
DuloxetineDULOXETINEBryant Ranch Prepack726b3c3e-8266-4a8a-a426-899cecd4f87e2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090776
rxcui: 596934
unii: 9044SC542W
DRIZALMA SPRINKLEDULOXETINESUN PHARMACEUTICAL INDUSTRIES, INC.b41423b8-dfec-4d79-ba3c-e43a87803d852024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DULOXETINEDULOXETINEBryant Ranch Prepack9a8cb289-0332-4835-960f-32d273092d152024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack675f999d-46b2-45da-b17e-58cc2ba180b12024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb1f1345c-3b7f-4228-b7b7-b9a4648050e52024-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBluePoint Laboratoriesa95cc04c-58e9-487f-8992-ef30df03a3cd2024-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP41c86c02-68c0-4db5-af1a-941b0d2ffe112024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutions6b1cac95-83e3-4fad-8d60-7a1a9e675eb22023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutionsb6040e79-0bbd-41a3-ba86-2a360a41864c2023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEA-S Medication Solutions07a7dd8d-cbf8-4281-8583-d2d98711ed6c2023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINE HYDROCHLORIDEMARKSANS PHARMA LIMITED3686cde5-f76d-4d16-aa5d-caceb8408f8c2023-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEProficient Rx LPf5e7503a-b28f-4cd0-a4ee-47bdca88d54b2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9044SC542W
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdcfd62c7-1687-4e9b-9ae4-5a44929ac7652023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
DuloxetineDULOXETINEProficient Rx LP5410084d-a7db-4da1-a45d-24b91ef504042022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP22a8cc15-17fb-4c4e-8d2a-de5755ed60312022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEAsclemed USA, Inc.7c755ca3-0855-4b54-80a8-01b85f8e644a2022-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090776
rxcui: 596930
unii: 9044SC542W

Reported adverse events (FAERS/openFDA)#

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