FDA.reportPublic FDA data

SEROQUEL

Product NDC
67046-664
11-digit product format
670460664
Labeler code
67046
Product ID
67046-664_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA020639
Marketing category
NDA
Marketing start
2010-06-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-664-302019-10-21C16284748780-1956f9ecf-dc38-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use SEROQUEL safely and effectively. See full prescribing information for SEROQUEL. SEROQUEL ® (quetiapine fumarate) Tablets Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-664-30SEROQUEL30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-664SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100616_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
317174QUEtiapine fumarate 200 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312744QUEtiapine fumarate 25 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312745QUEtiapine fumarate 300 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616483QUEtiapine fumarate 400 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616487QUEtiapine fumarate 50 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153639SEROquel 100 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153640SeroQUEL 200 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153638SeroQUEL 25 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
284509SeroQUEL 300 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616485SeroQUEL 400 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616489SeroQUEL 50 MG Oral TabletPSN276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153639quetiapine 100 MG Oral Tablet [Seroquel]SBD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153640quetiapine 200 MG Oral Tablet [Seroquel]SBD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153638quetiapine 25 MG Oral Tablet [Seroquel]SBD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
284509quetiapine 300 MG Oral Tablet [Seroquel]SBD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616485quetiapine 400 MG Oral Tablet [Seroquel]SBD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616489quetiapine 50 MG Oral Tablet [Seroquel]SBD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312743quetiapine 100 MG Oral TabletSCD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
317174quetiapine 200 MG Oral TabletSCD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312744quetiapine 25 MG Oral TabletSCD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312745quetiapine 300 MG Oral TabletSCD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616483quetiapine 400 MG Oral TabletSCD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616487quetiapine 50 MG Oral TabletSCD276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153639Seroquel 100 MG (as quetiapine fumarate) Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153639Seroquel 100 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153640Seroquel 200 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153638Seroquel 25 MG (as quetiapine fumarate) Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
153638Seroquel 25 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
284509Seroquel 300 MG (as quetiapine fumarate) Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
284509Seroquel 300 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616485Seroquel 400 MG (as quetiapine fumarate) Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616485Seroquel 400 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616489Seroquel 50 MG (as quetiapine fumarate) Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1
616489Seroquel 50 MG Oral TabletSY276e53bf-d3c0-4457-a76e-ee39c1cd2a3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-664-306704606643030 in 1 BLISTER PACKHistorical