FDA.reportPublic FDA data

SEROQUEL

Product NDC
0310-0281
11-digit product format
003100281
Labeler code
0310
Product ID
0310-0281_8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022047
Marketing category
NDA
Marketing start
2009-02-01
Marketing end
2027-06-30
Substance
QUETIAPINE FUMARATE
Active strength
150 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SEROQUEL
Brand name suffix
XR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-0281-39SEROQUELXR100 in 1 DOSE PACKTABLET, EXTENDED RELEASE10047
0310-0281-60SEROQUELXR60 in 1 BOTTLETABLET, EXTENDED RELEASE6047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0281-39EA - Each0310-028196baae81-57ed-43f3-921e-e21c08e5aa2d12012-07-24
0310-0281-60EA - Each0310-0281e3d9dcbe-5043-40ac-af76-233614158c9912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-0281SEROQUEL XR (QUETIAPINE) TABLET, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]47Current NDC, Legacy NDC, 2 package rows20250313_473a3ac4-67f4-4782-baa9-7f9bdd8761f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895671SEROQUEL XR 150 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721793SEROQUEL XR 200 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721797SEROQUEL XR 400 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853202SEROQUEL XR 50 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
89567124 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179324 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179524 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179724 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
85320224 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
89567124 HR Seroquel 150 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179324 HR Seroquel 200 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179524 HR Seroquel 300 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179724 HR Seroquel 400 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
85320224 HR Seroquel 50 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895671Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721793Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721795Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721797Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853202Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895671SEROQUEL XR 150 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721793SEROQUEL XR 200 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721797SEROQUEL XR 400 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853202SEROQUEL XR 50 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567124 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179324 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179524 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179724 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320224 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567124 HR Seroquel 150 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179324 HR Seroquel 200 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179524 HR Seroquel 300 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179724 HR Seroquel 400 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320224 HR Seroquel 50 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895671Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721793Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721795Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721797Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853202Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-0281-3900310028139100 in 1 DOSE PACKHistorical
0310-0281-600031002816060 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0281-60) 2009-02-012027-06-30NoNoCurrent