FDA.reportPublic FDA data

fluoxetine 25 MG / olanzapine 12 MG Oral Capsule

RxCUI
403970
RxNorm name
fluoxetine 25 MG / olanzapine 12 MG Oral Capsule
Display name
fluoxetine 25 MG / olanzapine 12 MG Oral Capsule
Full name
fluoxetine 25 MG / olanzapine 12 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

RxNav Current And Historical NDCs#

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

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINETeva Pharmaceuticals USA, Inc.3c28cf18-01a3-468a-ab3e-8aa82f9182512026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403970
Olanzapine and FluoxetineOLANZAPINE AND FUOXETINEPar Health USA, LLC2f6ceda3-3edc-4427-98a6-23e3c930c44d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403970
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINEAvKAREf5f78ed2-4640-8528-c51c-d7bffa045d482025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403970

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3c28cf18-01a3-468a-ab3e-8aa82f918251OLANZapine 12 MG / FLUoxetine HCl 25 MG Oral Capsule [PSN] · fluoxetine 25 MG / olanzapine 12 MG Oral Capsule [SCD] · fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule [SY]328These highlights do not include all the information needed to use OLANZAPINE AND FLUOXETINE CAPSULES safely and effectively. See full prescribing information for OLANZAPINE AND FLUOXETINE CAPSULES. OLANZAPINE and FLUOXETINE capsules, for oral use Initial U.S. Approval: 200320260331
2f6ceda3-3edc-4427-98a6-23e3c930c44dOLANZapine 12 MG / FLUoxetine HCl 25 MG Oral Capsule [PSN] · fluoxetine 25 MG / olanzapine 12 MG Oral Capsule [SCD] · fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule [SY]322These highlights do not include all the information needed to use OLANZAPINE AND FLUOXETINE CAPSULES safely and effectively. See full prescribing information for OLANZAPINE AND FLUOXETINE CAPSULES. OLANZAPINE and FLUOXETINE capsules, for oral use Initial U.S. Approval: 200320260331
f5f78ed2-4640-8528-c51c-d7bffa045d48OLANZapine 12 MG / FLUoxetine HCl 25 MG Oral Capsule [PSN] · fluoxetine 25 MG / olanzapine 12 MG Oral Capsule [SCD] · fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral Capsule [SY]38Olanzapine and Fluoxetine Capsules USP Rx Only These highlights do not include all the information needed to use OLANZAPINE AND FLUOXETINE CAPSULES safely and effectively. See full prescribing information for OLANZAPINE AND FLUOXETINE CAPSULES. OLANZAPINE and FLUOXETINE capsules, for oral use Initial U.S. Approval: 200320251015