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 7 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEBryant Ranch Prepack493a5946-e750-4500-afd1-8f3fdc1d420e2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.80e52273-9741-6aef-eb24-8a93ead85ba72024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma180a07fd-1f6a-4617-b8e0-f938c65ba2732024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEMedsource Pharmaceuticals1302fc08-d5fa-54b4-e063-6394a90a52752024-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthStar Rx LLC97960730-432e-4e94-bb4e-62a3157270a82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d7a4db7f-cdac-2b36-e053-2995a90a8d642024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited5336ce59-7a6c-4db9-8512-299cc5e599c02024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited3daecd20-6a59-44d3-8269-4912214c08b42024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited3195db14-0cae-4b49-9fba-49b869fe92a82024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions578ca8f8-86eb-4247-a0b3-50c3837a982e2024-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions08f3c11c-9ba0-4c53-bf31-264725e611ea2023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions3fba8d68-0663-4053-93ee-7531246fd47d2023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEScieGen Pharmaceuticals, Incb5035f61-693e-4386-8a07-3c36a6a469172023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions224c8c17-0183-4cd7-ab9e-0062f3c624f02023-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEUpsher-Smith Laboratories, LLCbe2e4325-feb9-4957-99c0-0a741a2d71a02023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionsc4eeae3d-ae56-4e7e-b07d-02851f12039f2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEMARKSANS PHARMA LIMITED8e822937-9431-446f-88c4-330a25d124392023-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs9f069b9b-16e4-4f0e-b420-4aa02ffbb6322023-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEDr.Reddy's Laboratories Limited11544dea-2f5e-1536-584a-5d1f37a997702023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDELannett Company, Inc.c856d72f-4a1a-4f75-ae54-c4ac83ddcfa12023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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