FDA.reportPublic FDA data

QUETIAPINE FUMARATE

Product NDC
63629-4841
11-digit product format
636294841
Labeler code
63629
Product ID
63629-4841_8042cb5a-fa9c-4089-98dc-00d012cb7ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
Substance
QUETIAPINE FUMARATE
Active strength
50 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUETIAPINE FUMARATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui616487

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
63629-4841-12022-01-06C16284748780-19d75b9d0-d60c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-22022-01-06C16284748780-19d75b9d0-d60c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-32022-01-06C16284748780-19d75b9d0-d60c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-12020-01-31C16284748780-19d75b9d0-d60c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-22020-01-31C16284748780-19d75b9d0-d60c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-32020-01-31C16284748780-19d75b9d0-d60c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4841-1QUETIAPINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED301010
63629-4841-2QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, FILM COATED601010
63629-4841-3QUETIAPINE FUMARATE90 in 1 BOTTLETABLET, FILM COATED901010
63629-4841-4QUETIAPINE FUMARATE25 in 1 BOTTLETABLET, FILM COATED251010
63629-4841-5QUETIAPINE FUMARATE120 in 1 BOTTLETABLET, FILM COATED1201010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4841-1EA - Each63629-4841292788f9-441f-439a-a5c3-7080a05b093612015-10-02
63629-4841-2EA - Each63629-4841df4e0f5a-debd-41c9-8dfc-e7bc3603b73412017-03-06
63629-4841-3EA - Each63629-4841f3d5fcc3-5659-44b9-a394-0eeb89b9369512018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4841QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1009Current NDC, Legacy NDC, 5 package rows20240820_a45d8b77-f13d-41c5-8d50-15152fc6f85c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNa45d8b77-f13d-41c5-8d50-15152fc6f85c1010
616487quetiapine 50 MG Oral TabletSCDa45d8b77-f13d-41c5-8d50-15152fc6f85c1010
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYa45d8b77-f13d-41c5-8d50-15152fc6f85c1010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4841-16362948410130 TABLET, FILM COATED in 1 BOTTLE (63629-4841-1) 2012-11-090000-00-00NoNoCurrent
63629-4841-26362948410260 TABLET, FILM COATED in 1 BOTTLE (63629-4841-2) 2016-10-110000-00-00NoNoCurrent
63629-4841-36362948410390 TABLET, FILM COATED in 1 BOTTLE (63629-4841-3) 2016-04-200000-00-00NoNoCurrent
63629-4841-46362948410425 TABLET, FILM COATED in 1 BOTTLE (63629-4841-4) 2024-08-080000-00-00NoNoCurrent
63629-4841-563629484105120 TABLET, FILM COATED in 1 BOTTLE (63629-4841-5) 2024-08-080000-00-00NoNoCurrent