FDA.reportPublic FDA data

QUEtiapine fumarate 400 MG Oral Tablet

RxCUI
616483
RxNorm name
QUEtiapine fumarate 400 MG Oral Tablet
Display name
QUEtiapine fumarate 400 MG Oral Tablet
Full name
QUEtiapine fumarate 400 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINEAscend Laboratories, LLC3112a006-1c61-47f2-84f5-9a7670d09c9b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.d38f0f4e-dc0f-4c92-a212-c4da3db748012026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATENorthStar Rx LLCe6e25ef9-2671-489e-8eca-58bedb4f59ab2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef62026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine fumarateQUETIAPINE FUMARATELupin Pharmaceuticals, Inc.a951cd63-d329-47c9-965a-582fa73a07c62026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine fumarateQUETIAPINE FUMARATESun Pharmaceutical Industries, Inc.ffe52b98-9872-48c1-90fd-8fcd37c3432f2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine fumarateQUETIAPINEAmerican Health Packaging9f927ae2-a0ae-4953-99ba-8de59ee5bfca2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack897184b1-de3c-4d59-91be-3069325fd5b22026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
SEROQUELQUETIAPINEH2-Pharma, LLC8ae62aaf-f8c5-417f-baac-0098369ca3222026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
QuetiapineQUETIAPINEBryant Ranch Prepackcb989abf-7d73-4ab9-a07f-a8c9de50389f2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine fumarateQUETIAPINEBluePoint Laboratories874e50ad-5da0-4ac3-9290-79442c91399e2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATEXLCare Pharmaceuticals Inc.070faf07-0ce7-4354-8643-9d222b72ecad2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions55018271-1f8f-4683-afee-8203c3bd9acc2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATEAvPAK6b7d7d2f-a50b-8e21-2de4-ccc1020163842025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
QuetiapineQUETIAPINEAccord Healthcare Inc.2d77412a-e084-4406-ac33-d882aece93542025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATERising Pharma Holdings, Inc.532c8ace-4cf5-4a08-bae7-2af8c41ffa3d2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
QuetiapineQUETIAPINEASCLEMED USA INC.74e09734-26cb-42fe-b9a3-79cc10505e0b2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
Quetiapine FumarateQUETIAPINE FUMARATEAurobindo Pharma Limited8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b62025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
QuetiapineQUETIAPINETeva Pharmaceuticals USA, Inc.c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
QUETIAPINEQUETIAPINESolco Healthcare US, LLC61b1230e-c0dc-46c6-a577-7d5dd2515eb72025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483

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 2 of 2 · 44 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
74e09734-26cb-42fe-b9a3-79cc10505e0bQUEtiapine fumarate 400 MG Oral Tablet [PSN] · quetiapine 400 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 400 MG Oral Tablet [SY]31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 199720251020
6258bbaf-4ac0-4621-b95e-e6b032aa0518QUEtiapine fumarate 400 MG Oral Tablet [PSN] · quetiapine 400 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 400 MG Oral Tablet [SY]31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 199720200201
fb10b12a-0017-47a2-9826-e403ac6a77a7QUEtiapine fumarate 400 MG Oral Tablet [PSN] · quetiapine 400 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 400 MG Oral Tablet [SY]31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS QUETIAPINE tablets, for oral use Initial U.S. Approval: 199720190624
a65d98ac-09eb-41c3-b43a-2f25f892edcdQUEtiapine fumarate 400 MG Oral Tablet [PSN] · quetiapine 400 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 400 MG Oral Tablet [SY]31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 199720170323