FDA.reportPublic FDA data

FLUoxetine 20 MG in 5 mL Oral Solution

RxCUI
310386
RxNorm name
FLUoxetine 20 MG in 5 mL Oral Solution
Display name
FLUoxetine 20 MG in 5 mL Oral Solution
Full name
FLUoxetine 20 MG in 5 mL Oral Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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No records found.

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEChartwell Governmental & Specialty RX, LLCd34362ed-e821-4c55-9f8c-3dfb772b1b2a2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
FluoxetineFLUOXETINEChartwell RX, LLCcac17277-3481-4661-935f-efc48fff534c2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDEANI Pharmaceuticals, Inc.1ffe57c3-6f70-4075-aacb-d87a3990fdea2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
FLUOXETINEFLUOXETINESaptalis Pharmaceuticals, LLC.4527c502-b28c-449f-ad2d-7daf21563cfa2025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
FluoxetineFLUOXETINEAmerican Health Packaging3276a2a4-61c7-4de6-b519-3aa8b62da88f2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
FluoxetineFLUOXETINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma180a07fd-1f6a-4617-b8e0-f938c65ba2732024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
FluoxetineFLUOXETINEAurobindo Pharma Limited3195db14-0cae-4b49-9fba-49b869fe92a82024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEUpsher-Smith Laboratories, LLCbe2e4325-feb9-4957-99c0-0a741a2d71a02023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386
FluoxetineFLUOXETINE HYDROCHLORIDELannett Company, Inc.c856d72f-4a1a-4f75-ae54-c4ac83ddcfa12023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310386

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1FLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]439These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution, for oral use Initial U.S. Approval: 199120230828
3195db14-0cae-4b49-9fba-49b869fe92a8FLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]424These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution Initial U.S. Approval: 198720240122
180a07fd-1f6a-4617-b8e0-f938c65ba273FLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]413Fluoxetine Oral Solution USP These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for Fluoxetine Oral Solution USP. Fluoxetine Oral Solution USP for oral use Initial U.S. Approval: 199120240319
1ffe57c3-6f70-4075-aacb-d87a3990fdeaFLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]46These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution Initial U.S. Approval: 199120260105
cac17277-3481-4661-935f-efc48fff534cFLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]45FLUOXETINE oral solution These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution, for oral use Initial U.S. Approval: 199120260205
be2e4325-feb9-4957-99c0-0a741a2d71a0FLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]45These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution Initial U.S. Approval: 199120231006
ff94753e-8284-4a58-bc4d-b92703c22163FLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]44These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution, for oral use Initial U.S. Approval: 198720230801
3276a2a4-61c7-4de6-b519-3aa8b62da88fFLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]43These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution Initial U.S. Approval: 198720250404
d34362ed-e821-4c55-9f8c-3dfb772b1b2aFLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]42FLUOXETINE oral solution These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution, for oral use Initial U.S. Approval: 199120260211
4527c502-b28c-449f-ad2d-7daf21563cfaFLUoxetine 20 MG in 5 mL Oral Solution [PSN] · fluoxetine 4 MG/ML Oral Solution [SCD] · fluoxetine 20 MG per 5 ML Oral Solution [SY] · fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution [SY]41These highlights do not include all the information needed to use FLUOXETINE ORAL SOLUTION safely and effectively. See full prescribing information for FLUOXETINE ORAL SOLUTION. FLUOXETINE oral solution, for oral use Initial U.S. Approval: 198720250623