SEROQUEL

Product NDC
21695-117
11-digit product format
216950117
Labeler code
21695
Product ID
21695-117_3dc79540-2f24-4920-99cd-ef6482f68eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020639
Marketing category
NDA
Marketing start
2010-06-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
25 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-117-25SEROQUEL15 in 1 BOTTLETABLET, FILM COATED151

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-117SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_3dc79540-2f24-4920-99cd-ef6482f68eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
317174QUEtiapine fumarate 200 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
312744QUEtiapine fumarate 25 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
616487QUEtiapine fumarate 50 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
153639SEROquel 100 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
153640SeroQUEL 200 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
153638SeroQUEL 25 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
616489SeroQUEL 50 MG Oral TabletPSN3dc79540-2f24-4920-99cd-ef6482f68eb21
153639quetiapine 100 MG Oral Tablet [Seroquel]SBD3dc79540-2f24-4920-99cd-ef6482f68eb21
153640quetiapine 200 MG Oral Tablet [Seroquel]SBD3dc79540-2f24-4920-99cd-ef6482f68eb21
153638quetiapine 25 MG Oral Tablet [Seroquel]SBD3dc79540-2f24-4920-99cd-ef6482f68eb21
616489quetiapine 50 MG Oral Tablet [Seroquel]SBD3dc79540-2f24-4920-99cd-ef6482f68eb21
312743quetiapine 100 MG Oral TabletSCD3dc79540-2f24-4920-99cd-ef6482f68eb21
317174quetiapine 200 MG Oral TabletSCD3dc79540-2f24-4920-99cd-ef6482f68eb21
312744quetiapine 25 MG Oral TabletSCD3dc79540-2f24-4920-99cd-ef6482f68eb21
616487quetiapine 50 MG Oral TabletSCD3dc79540-2f24-4920-99cd-ef6482f68eb21
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
153639Seroquel 100 MG (as quetiapine fumarate) Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
153639Seroquel 100 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
153640Seroquel 200 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
153638Seroquel 25 MG (as quetiapine fumarate) Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
153638Seroquel 25 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
616489Seroquel 50 MG (as quetiapine fumarate) Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21
616489Seroquel 50 MG Oral TabletSY3dc79540-2f24-4920-99cd-ef6482f68eb21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-117-252169501172515 in 1 BOTTLEHistorical