FDA.reportPublic FDA data

NDC 80425-0313-01 - Fluoxetine

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
80425-0313
Requested NDC
80425-0313-01
Package NDCs from labels
80425-0313-1, 80425-0313-2, 80425-0313-3, 80425-0313-01
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
Fluoxetine - 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
80425-0313-1Fluoxetine30 in 1 BOTTLECAPSULE302
80425-0313-2Fluoxetine60 in 1 BOTTLECAPSULE602
80425-0313-3Fluoxetine90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0313FLUOXETINE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f917063a-226e-0978-e053-6294a90aeb4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0313-1EA - Each80425-0313b8d1d31a-fff6-4b9c-a9b3-e011b8c7eb4712023-06-06
80425-0313-2EA - Each80425-0313829bc627-e21e-4aa1-99b3-4b8ba39cdb6f12023-06-06
80425-0313-3EA - Each80425-0313562d5109-ba29-492b-84e6-90b21d9adfc712023-06-06

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 3 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEA-S Medication Solutions3ce2f189-4386-4d0d-84f6-6d913ad1c09b2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEREMEDYREPACK INC.a1b40d46-5233-49d7-9833-762cb69990122026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENCS HealthCare of KY, LLC dba Vangard Labsfaf4bc0c-bf65-4a65-8f08-3d800185d6a82026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENorthwind Health Company, LLC4dee4a1a-360c-532e-e063-6394a90a84262026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINETeva Pharmaceuticals USA, Inc.3c28cf18-01a3-468a-ab3e-8aa82f9182512026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDERADHA PHARMACEUTICALS, INC.1a07ebe9-3661-4a48-b8af-9b228875166a2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBluePoint Laboratoriesdaf33244-1348-4c34-b44c-9e35d5c48a3e2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack3ccada47-7eb9-285d-5059-06afb44661142026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackbb06af33-8ff7-0b02-0029-d628f62e13822026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack77d5c10a-0cfc-4b89-942c-0fb5c67ae4092026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEA-S Medication Solutions2c8970ad-2266-4653-b7eb-4c79ba926d892026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINELegacy Pharmaceutical Packaging, LLCb07f9eab-44ac-4667-bd46-52d736daa5d62026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEA-S Medication Solutions096e9438-2bed-434b-aa56-a6d55471fef12026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions2c56a437-f6bf-4ac8-b1d9-fc8a605a97e72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d232026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEChartwell Governmental & Specialty RX, LLCd34362ed-e821-4c55-9f8c-3dfb772b1b2a2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEChartwell RX, LLCcac17277-3481-4661-935f-efc48fff534c2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEAurobindo Pharma Limited45454555-7402-41cb-a452-e6a76e04f3872026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
ProzacFLUOXETINE HYDROCHLORIDEDista Products Companyc88f33ed-6dfb-4c5e-bc01-d8e36dd972992026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDEANI Pharmaceuticals, Inc.1ffe57c3-6f70-4075-aacb-d87a3990fdea2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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