FDA.reportPublic FDA data

quetiapine fumarate

Product NDC
43353-788
11-digit product format
433530788
Labeler code
43353
Product ID
43353-788_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090960
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
43353-788-302020-01-31C16284748780-19d75b9d1-2aae-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 Initial U.S. Approval: 1997
43353-788-532020-01-31C16284748780-19d75b9d1-2aae-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 Initial U.S. Approval: 1997
43353-788-602020-01-31C16284748780-19d75b9d1-2aae-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 Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-788-30quetiapine fumarate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
43353-788-53quetiapine fumarate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
43353-788-60quetiapine fumarate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-788-30EA - Each43353-78812a4a9db-6936-4206-8368-3a69f45000d012013-04-01
43353-788-53EA - Each43353-7884d313e0e-55b1-4dbd-91f5-5c85e462b4e612013-04-01
43353-788-60EA - Each43353-78881ab9bab-aed4-4eae-bd9d-77cad34343f612013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-788QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 3 package rows20140429_94dfc588-1fd9-4435-93ec-c6dd4700aef5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN94dfc588-1fd9-4435-93ec-c6dd4700aef52
317174QUEtiapine fumarate 200 MG Oral TabletPSN94dfc588-1fd9-4435-93ec-c6dd4700aef52
312744QUEtiapine fumarate 25 MG Oral TabletPSN94dfc588-1fd9-4435-93ec-c6dd4700aef52
312745QUEtiapine fumarate 300 MG Oral TabletPSN94dfc588-1fd9-4435-93ec-c6dd4700aef52
616483QUEtiapine fumarate 400 MG Oral TabletPSN94dfc588-1fd9-4435-93ec-c6dd4700aef52
312743quetiapine 100 MG Oral TabletSCD94dfc588-1fd9-4435-93ec-c6dd4700aef52
317174quetiapine 200 MG Oral TabletSCD94dfc588-1fd9-4435-93ec-c6dd4700aef52
312744quetiapine 25 MG Oral TabletSCD94dfc588-1fd9-4435-93ec-c6dd4700aef52
312745quetiapine 300 MG Oral TabletSCD94dfc588-1fd9-4435-93ec-c6dd4700aef52
616483quetiapine 400 MG Oral TabletSCD94dfc588-1fd9-4435-93ec-c6dd4700aef52
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY94dfc588-1fd9-4435-93ec-c6dd4700aef52
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY94dfc588-1fd9-4435-93ec-c6dd4700aef52
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY94dfc588-1fd9-4435-93ec-c6dd4700aef52
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY94dfc588-1fd9-4435-93ec-c6dd4700aef52
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY94dfc588-1fd9-4435-93ec-c6dd4700aef52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-788-304335307883030 in 1 BOTTLE, PLASTICHistorical
43353-788-534335307885360 in 1 BOTTLE, PLASTICHistorical
43353-788-604335307886090 in 1 BOTTLE, PLASTICHistorical