FDA.reportPublic FDA data

fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule

RxCUI
313995
RxNorm name
fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule
Display name
fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule
Full name
fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

RxNav Current And Historical NDCs#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr.Reddy's Laboratories Limited887fc670-db67-4cfe-967b-46b38375dae52026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313995

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
887fc670-db67-4cfe-967b-46b38375dae5FLUoxetine 90 MG Delayed Release Oral Capsule [PSN] · fluoxetine 90 MG Delayed Release Oral Capsule [SCD] · fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule [SY]320These highlights do not include all the information needed to use FLUOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE DELAYED-RELEASE CAPSULES. FLUOXETINE delayed-release capsules (once-weekly), for oral use Initial U.S. Approval: 200120250520