FDA.reportPublic FDA data

Quetiapine

Product NDC
67877-245
11-digit product format
678770245
Labeler code
67877
Product ID
67877-245_96978e8e-30c0-4844-a195-a42abd9615b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
Substance
QUETIAPINE FUMARATE
Active strength
150 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 312744, 312745, 317174, 389201, 616483, 616487

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-245-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10040
67877-245-33Quetiapine1 in 1 CARTONTABLET, FILM COATED140
67877-245-33Quetiapine10 in 1 BLISTER PACKTABLET, FILM COATED1040
67877-245-38Quetiapine10 in 1 CARTONTABLET, FILM COATED1040
67877-245-38Quetiapine10 in 1 BLISTER PACKTABLET, FILM COATED1040

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
POVIDONE K30INACTIVE INGREDIENTU725QWY32XQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-245QUETIAPINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]40Current NDC, Legacy NDC, 5 package rows20250524_3112a006-1c61-47f2-84f5-9a7670d09c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
389201QUEtiapine fumarate 150 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
317174QUEtiapine fumarate 200 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
312744QUEtiapine fumarate 25 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
312745QUEtiapine fumarate 300 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
616483QUEtiapine fumarate 400 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
616487QUEtiapine fumarate 50 MG Oral TabletPSN3112a006-1c61-47f2-84f5-9a7670d09c9b40
312743quetiapine 100 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
389201quetiapine 150 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
317174quetiapine 200 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
312744quetiapine 25 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
312745quetiapine 300 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
616483quetiapine 400 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
616487quetiapine 50 MG Oral TabletSCD3112a006-1c61-47f2-84f5-9a7670d09c9b40
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
389201quetiapine (as quetiapine fumarate) 150 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY3112a006-1c61-47f2-84f5-9a7670d09c9b40
312743QUEtiapine fumarate 100 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
389201QUEtiapine fumarate 150 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
317174QUEtiapine fumarate 200 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
312744QUEtiapine fumarate 25 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
312745QUEtiapine fumarate 300 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
616483QUEtiapine fumarate 400 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
616487QUEtiapine fumarate 50 MG Oral TabletPSN74e09734-26cb-42fe-b9a3-79cc10505e0b1
312743quetiapine 100 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
389201quetiapine 150 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
317174quetiapine 200 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
312744quetiapine 25 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
312745quetiapine 300 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
616483quetiapine 400 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
616487quetiapine 50 MG Oral TabletSCD74e09734-26cb-42fe-b9a3-79cc10505e0b1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1
389201quetiapine (as quetiapine fumarate) 150 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY74e09734-26cb-42fe-b9a3-79cc10505e0b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-245-0167877024501100 TABLET, FILM COATED in 1 BOTTLE (67877-245-01) 2013-03-010000-00-00NoNoCurrent
67877-245-33678770245331 BLISTER PACK in 1 CARTON (67877-245-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-03-010000-00-00NoNoCurrent
67877-245-386787702453810 BLISTER PACK in 1 CARTON (67877-245-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-03-010000-00-00NoNoCurrent