FDA.reportPublic FDA data

QUEtiapine fumarate 300 MG Oral Tablet

RxCUI
312745
RxNorm name
QUEtiapine fumarate 300 MG Oral Tablet
Display name
QUEtiapine fumarate 300 MG Oral Tablet
Full name
QUEtiapine fumarate 300 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

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 · 37 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: 312745
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.695415b1-083d-4540-9f41-bde4b201f8342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack94a81681-381e-4b3b-89ac-e86dcbe7f8902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATENorthStar Rx LLCe6e25ef9-2671-489e-8eca-58bedb4f59ab2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINECoupler LLC544f6e91-e61f-c57a-e063-6294a90af9d12026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINE FUMARATELupin Pharmaceuticals, Inc.a951cd63-d329-47c9-965a-582fa73a07c62026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINE FUMARATESun Pharmaceutical Industries, Inc.ffe52b98-9872-48c1-90fd-8fcd37c3432f2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINEAmerican Health Packaging9f927ae2-a0ae-4953-99ba-8de59ee5bfca2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.da5c118f-404c-4453-aa10-a8656b1d75012026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
SEROQUELQUETIAPINEH2-Pharma, LLC8ae62aaf-f8c5-417f-baac-0098369ca3222026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf0ad842c-a0c2-4855-a55b-353b5338980f2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.16f48034-b8c9-ab2b-e063-6294a90adf652026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINEBluePoint Laboratories874e50ad-5da0-4ac3-9290-79442c91399e2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATEXLCare Pharmaceuticals Inc.070faf07-0ce7-4354-8643-9d222b72ecad2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions42bd7dd3-9f81-4d8b-bce9-302e5559da2f2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.471d8e2d-4be6-6180-e063-6394a90ac7212025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATEAvPAK6b7d7d2f-a50b-8e21-2de4-ccc1020163842025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
QuetiapineQUETIAPINEAccord Healthcare Inc.2d77412a-e084-4406-ac33-d882aece93542025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
Quetiapine FumarateQUETIAPINE FUMARATERising Pharma Holdings, Inc.532c8ace-4cf5-4a08-bae7-2af8c41ffa3d2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
QuetiapineQUETIAPINEASCLEMED USA INC.74e09734-26cb-42fe-b9a3-79cc10505e0b2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745

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 · 46 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
471d8e2d-4be6-6180-e063-6394a90ac721QUEtiapine fumarate 300 MG Oral Tablet [PSN] · quetiapine 300 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 300 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: 199720251229
74e09734-26cb-42fe-b9a3-79cc10505e0bQUEtiapine fumarate 300 MG Oral Tablet [PSN] · quetiapine 300 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 300 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
b7aa0fce-1406-4665-a791-e30aed7b24ffQUEtiapine fumarate 300 MG Oral Tablet [PSN] · quetiapine 300 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 300 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: 199720250820
dfb4820d-d34f-2ddf-e053-2a95a90a9c21QUEtiapine fumarate 300 MG Oral Tablet [PSN] · quetiapine 300 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 300 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: 199720220523
5a19e429-21d0-efd1-e053-2a91aa0acb63QUEtiapine fumarate 300 MG Oral Tablet [PSN] · quetiapine 300 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 300 MG Oral Tablet [SY]31636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 199720170926
5a1a6ce6-741d-6941-e053-2a91aa0a83e7QUEtiapine fumarate 300 MG Oral Tablet [PSN] · quetiapine 300 MG Oral Tablet [SCD] · quetiapine (as quetiapine fumarate) 300 MG Oral Tablet [SY]31620 Quetiapine 100 mg 621 Quetiapine 200 mg 622 Quetiapine 300 mg These 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: 199720170926