FDA.reportPublic FDA data

SEROQUEL

Product NDC
64725-0284
11-digit product format
647250284
Labeler code
64725
Product ID
64725-0284_09f9c7b9-7622-4089-b6b9-8e5be366a398
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
NDA022047
Marketing category
NDA
Marketing start
2007-07-16
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
400 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0284-12020-01-31C16284748780-19d75b9d1-14cd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SEROQUEL XR safely and effectively. See full prescribing information for SEROQUEL XR. SEROQUEL XR (quetiapine fumarate) extended-release tablets, for oral use Initial U.S. Approval: 1997 ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0284-1SEROQUEL XR60 in 1 BOTTLETABLET, EXTENDED RELEASE6010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0284SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10Legacy NDC, 1 package rows20141110_51927f2e-3d56-4644-a6a8-40e0b9a5b579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895671SEROQUEL XR 150 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721793SEROQUEL XR 200 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721797SEROQUEL XR 400 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853202SEROQUEL XR 50 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567124 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179324 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179524 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179724 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320224 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567124 HR Seroquel 150 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179324 HR Seroquel 200 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179524 HR Seroquel 300 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179724 HR Seroquel 400 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320224 HR Seroquel 50 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895671Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721793Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721795Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721797Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853202Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0284-16472502840160 in 1 BOTTLEHistorical