FDA.reportPublic FDA data

SEROQUEL

Product NDC
0310-0272
11-digit product format
003100272
Labeler code
0310
Product ID
0310-0272_aef69992-4a20-4d55-b85c-7c0799619ce6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA020639
Marketing category
NDA
Marketing start
1997-10-01
Marketing end
2027-06-30
Substance
QUETIAPINE FUMARATE
Active strength
200 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SEROQUEL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui153638, 153639, 153640, 284509, 312743, 312744, 312745, 317174, 616483, 616485, 616487, 616489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-0272-10SEROQUEL100 in 1 BOTTLETABLET, FILM COATED10050
0310-0272-39SEROQUEL1 in 1 BLISTER PACKTABLET, FILM COATED150
0310-0272-39SEROQUEL100 in 1 CARTONTABLET, FILM COATED10050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0272-10EA - Each0310-0272e997e48b-3c75-4cfb-abe2-24d69bc6394012012-07-24
0310-0272-39EA - Each0310-0272cb73287d-bd4a-44a9-8e52-868c97afd13512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]34
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
0310-0272SEROQUEL (QUETIAPINE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]50Current NDC, Legacy NDC, 3 package rows20250312_0584dda8-bc3c-48fe-1a90-79608f78e8a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
317174QUEtiapine fumarate 200 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
312744QUEtiapine fumarate 25 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
312745QUEtiapine fumarate 300 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
616483QUEtiapine fumarate 400 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
616487QUEtiapine fumarate 50 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
153639SEROquel 100 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
153640SeroQUEL 200 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
153638SeroQUEL 25 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
284509SeroQUEL 300 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
616485SeroQUEL 400 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
616489SeroQUEL 50 MG Oral TabletPSN0584dda8-bc3c-48fe-1a90-79608f78e8a050
153639quetiapine 100 MG Oral Tablet [Seroquel]SBD0584dda8-bc3c-48fe-1a90-79608f78e8a050
153640quetiapine 200 MG Oral Tablet [Seroquel]SBD0584dda8-bc3c-48fe-1a90-79608f78e8a050
153638quetiapine 25 MG Oral Tablet [Seroquel]SBD0584dda8-bc3c-48fe-1a90-79608f78e8a050
284509quetiapine 300 MG Oral Tablet [Seroquel]SBD0584dda8-bc3c-48fe-1a90-79608f78e8a050
616485quetiapine 400 MG Oral Tablet [Seroquel]SBD0584dda8-bc3c-48fe-1a90-79608f78e8a050
616489quetiapine 50 MG Oral Tablet [Seroquel]SBD0584dda8-bc3c-48fe-1a90-79608f78e8a050
312743quetiapine 100 MG Oral TabletSCD0584dda8-bc3c-48fe-1a90-79608f78e8a050
317174quetiapine 200 MG Oral TabletSCD0584dda8-bc3c-48fe-1a90-79608f78e8a050
312744quetiapine 25 MG Oral TabletSCD0584dda8-bc3c-48fe-1a90-79608f78e8a050
312745quetiapine 300 MG Oral TabletSCD0584dda8-bc3c-48fe-1a90-79608f78e8a050
616483quetiapine 400 MG Oral TabletSCD0584dda8-bc3c-48fe-1a90-79608f78e8a050
616487quetiapine 50 MG Oral TabletSCD0584dda8-bc3c-48fe-1a90-79608f78e8a050
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
153639Seroquel 100 MG (as quetiapine fumarate) Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
153639Seroquel 100 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
153640Seroquel 200 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
153638Seroquel 25 MG (as quetiapine fumarate) Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
153638Seroquel 25 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
284509Seroquel 300 MG (as quetiapine fumarate) Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
284509Seroquel 300 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
616485Seroquel 400 MG (as quetiapine fumarate) Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
616485Seroquel 400 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
616489Seroquel 50 MG (as quetiapine fumarate) Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
616489Seroquel 50 MG Oral TabletSY0584dda8-bc3c-48fe-1a90-79608f78e8a050
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-0272-1000310027210100 TABLET, FILM COATED in 1 BOTTLE (0310-0272-10) 1997-10-012027-06-30NoNoCurrent
0310-0272-39003100272391 in 1 BLISTER PACKHistorical