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 4 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCda6b9b19-2ea1-9a39-e053-2995a90ad7302026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCdfae4357-b6f9-9a30-e053-2995a90a26672026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCaae4e339-5244-f6f9-e053-2995a90a42ce2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCab1eec9d-f755-81a2-e053-2a95a90acb3c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCf2a48124-0790-51c2-e053-2a95a90aa1af2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCcb66a702-7670-4a73-98fb-0e63151a1ffb2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Olanzapine and FluoxetineOLANZAPINE AND FUOXETINEPar Health USA, LLC2f6ceda3-3edc-4427-98a6-23e3c930c44d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEQPharma Incb4831735-6731-473a-b4f0-1f4a67aa71202025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEQPharma Incfc754dff-cecb-fc6b-e053-6394a90ab3712025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionscdf3b608-e14c-474b-b80e-01ac5f7018662025-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionscca9edf9-2454-4bf9-98e8-c531a8f5dc422025-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310385
unii: I9W7N6B1KJ
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINEAvKAREf5f78ed2-4640-8528-c51c-d7bffa045d482025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepackc1c7ec04-dd9e-400f-8f49-e900945fc61c2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECardinal Health 107, LLC06394c4b-99f4-4257-bf29-53c170c5a0612025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.369dbfba-9de4-433c-8680-2ec047b8f8d92025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECouplerLLC3e111be4-28f0-c290-e063-6294a90a447f2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.3e8912e2-2a0c-5047-e063-6294a90a7e322025-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLC4abbd9d9-e9b1-463d-8f39-f3f50d80f58a2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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