FDA.reportPublic FDA data

Quetiapine

Product NDC
0093-8163
11-digit product format
000938163
Labeler code
0093
Product ID
0093-8163_5059f747-d59d-460b-99bc-7b76b235c094
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077745
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
200 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 312744, 312745, 317174, 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
0093-8163-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8163-01EA - Each0093-81632fb4259f-a3bd-45ef-9196-c2b627d7078412012-07-24
0093-8163-10EA - Each0093-8163d1ae151c-e995-4c1c-bca4-5b839e29980512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POVIDONE K26/28INACTIVE INGREDIENTH7AGY1OJO8QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POVIDONE K26/28INACTIVE INGREDIENTH7AGY1OJO8QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8163QUETIAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 1 package rows20250510_c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
317174QUEtiapine fumarate 200 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312744QUEtiapine fumarate 25 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312745QUEtiapine fumarate 300 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616483QUEtiapine fumarate 400 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616487QUEtiapine fumarate 50 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312743quetiapine 100 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
317174quetiapine 200 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312744quetiapine 25 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312745quetiapine 300 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616483quetiapine 400 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616487quetiapine 50 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312743QUEtiapine fumarate 100 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
317174QUEtiapine fumarate 200 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
312744QUEtiapine fumarate 25 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
312745QUEtiapine fumarate 300 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
616483QUEtiapine fumarate 400 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487QUEtiapine fumarate 50 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
312743quetiapine 100 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
317174quetiapine 200 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
312744quetiapine 25 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
312745quetiapine 300 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
616483quetiapine 400 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487quetiapine 50 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-8163-0100093816301100 TABLET, FILM COATED in 1 BOTTLE (0093-8163-01) 2012-03-270000-00-00NoNoCurrent