FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
43353-813
11-digit product format
433530813
Labeler code
43353
Product ID
43353-813_59a4aa04-8122-4125-95ef-b30e33c375ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090749
Marketing category
ANDA
Marketing start
2012-03-27
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
43353-813-302020-01-31C16284748780-19d75b9cf-f7fa-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Quetiapine Fumarate Tablets safely and effectively. See full prescribing information for Quetiapine Fumarate Tablets. Quetiapine Fumarate Tablets, for oral use Initial U.S. Approval: 1997
43353-813-532020-01-31C16284748780-19d75b9cf-f7fa-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Quetiapine Fumarate Tablets safely and effectively. See full prescribing information for Quetiapine Fumarate Tablets. Quetiapine Fumarate Tablets, for oral use Initial U.S. Approval: 1997
43353-813-602020-01-31C16284748780-19d75b9cf-f7fa-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Quetiapine Fumarate Tablets safely and effectively. See full prescribing information for Quetiapine Fumarate Tablets. Quetiapine Fumarate Tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-813-30Quetiapine Fumarate30 in 1 BOTTLE, PLASTICTABLET301
43353-813-53Quetiapine Fumarate60 in 1 BOTTLE, PLASTICTABLET601
43353-813-60Quetiapine Fumarate90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-813-30EA - Each43353-813712fbc3a-1d29-445c-9010-bebb99ad1d3912014-06-03
43353-813-53EA - Each43353-813efae6776-6bce-4547-9e80-2aae4642e73112014-06-03
43353-813-60EA - Each43353-813dfe1aba5-d886-4ea7-bd13-87c2463f075612014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GQUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQQUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RQUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-813QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20140509_3e482854-45ac-4de9-88a3-e5f70dbdc57b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN3e482854-45ac-4de9-88a3-e5f70dbdc57b1
317174QUEtiapine fumarate 200 MG Oral TabletPSN3e482854-45ac-4de9-88a3-e5f70dbdc57b1
312744QUEtiapine fumarate 25 MG Oral TabletPSN3e482854-45ac-4de9-88a3-e5f70dbdc57b1
312743quetiapine 100 MG Oral TabletSCD3e482854-45ac-4de9-88a3-e5f70dbdc57b1
317174quetiapine 200 MG Oral TabletSCD3e482854-45ac-4de9-88a3-e5f70dbdc57b1
312744quetiapine 25 MG Oral TabletSCD3e482854-45ac-4de9-88a3-e5f70dbdc57b1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY3e482854-45ac-4de9-88a3-e5f70dbdc57b1
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY3e482854-45ac-4de9-88a3-e5f70dbdc57b1
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY3e482854-45ac-4de9-88a3-e5f70dbdc57b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-813-304335308133030 in 1 BOTTLE, PLASTICHistorical
43353-813-534335308135360 in 1 BOTTLE, PLASTICHistorical
43353-813-604335308136090 in 1 BOTTLE, PLASTICHistorical