FDA.reportPublic FDA data

Quetiapine

Product NDC
67877-246
11-digit product format
678770246
Labeler code
67877
Product ID
67877-246_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
200 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 FUMARATE200 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
67877-246-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10040
67877-246-10Quetiapine1000 in 1 BOTTLETABLET, FILM COATED100040
67877-246-33Quetiapine1 in 1 CARTONTABLET, FILM COATED140
67877-246-33Quetiapine10 in 1 BLISTER PACKTABLET, FILM COATED1040
67877-246-38Quetiapine10 in 1 CARTONTABLET, FILM COATED1040
67877-246-38Quetiapine10 in 1 BLISTER PACKTABLET, FILM COATED1040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-246-01EA - Each67877-246b11cf044-de50-48c3-a0c3-767826be85dd12013-03-03
67877-246-10EA - Each67877-246adeec331-f19c-463e-bb78-769c3e64e67a12015-08-04
67877-246-33EA - Each67877-24621740c79-0dbf-4003-9cc7-83f9533b17b512013-04-01
67877-246-38EA - Each67877-246c1a581fc-97a3-45eb-aafc-701b7eb95fd112013-04-01

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
67877-246QUETIAPINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]40Current NDC, Legacy NDC, 6 package rows20250524_3112a006-1c61-47f2-84f5-9a7670d09c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN35b2069e-209a-41ac-84e6-377d4f19be87105
317174quetiapine 200 MG Oral TabletSCD35b2069e-209a-41ac-84e6-377d4f19be87105
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY35b2069e-209a-41ac-84e6-377d4f19be87105
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
317174QUEtiapine fumarate 200 MG Oral TabletPSN10288afa-c4dc-4897-9ec8-f4573d85077919
317174quetiapine 200 MG Oral TabletSCD10288afa-c4dc-4897-9ec8-f4573d85077919
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY10288afa-c4dc-4897-9ec8-f4573d85077919
312743QUEtiapine fumarate 100 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
317174QUEtiapine fumarate 200 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
312744QUEtiapine fumarate 25 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
312745QUEtiapine fumarate 300 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
616483QUEtiapine fumarate 400 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
616487QUEtiapine fumarate 50 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
312743quetiapine 100 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
317174quetiapine 200 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
312744quetiapine 25 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
312745quetiapine 300 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
616483quetiapine 400 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
616487quetiapine 50 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
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
67877-246-0167877024601100 TABLET, FILM COATED in 1 BOTTLE (67877-246-01) 2013-03-010000-00-00NoNoCurrent
67877-246-10678770246101000 TABLET, FILM COATED in 1 BOTTLE (67877-246-10) 2013-03-010000-00-00NoNoCurrent
67877-246-33678770246331 BLISTER PACK in 1 CARTON (67877-246-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-03-010000-00-00NoNoCurrent
67877-246-386787702463810 BLISTER PACK in 1 CARTON (67877-246-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-03-010000-00-00NoNoCurrent