FDA.reportPublic FDA data

SEROQUEL

Product NDC
61269-254
11-digit product format
612690254
Labeler code
61269
Product ID
61269-254_1fc7d584-a2f0-47f7-9506-5ecb2bfebb65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H2-Pharma, LLC
Application
NDA020639
Marketing category
NDA
Marketing start
2000-11-13
Substance
QUETIAPINE FUMARATE
Active strength
300 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
SEROQUEL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui153638, 153639, 153640, 284509, 312743, 312744, 312745, 317174, 616483, 616485, 616487, 616489

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
61269-254-60SEROQUEL60 in 1 BOTTLETABLET, FILM COATED6053

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-254-60EA - Each61269-254dc4599b3-2add-4137-91d9-931c08202a2312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
317174QUEtiapine fumarate 200 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
312744QUEtiapine fumarate 25 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
312745QUEtiapine fumarate 300 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
616483QUEtiapine fumarate 400 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
616487QUEtiapine fumarate 50 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
153639SEROquel 100 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
153640SeroQUEL 200 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
153638SeroQUEL 25 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
284509SeroQUEL 300 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
616485SeroQUEL 400 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
616489SeroQUEL 50 MG Oral TabletPSN8ae62aaf-f8c5-417f-baac-0098369ca32253
153639quetiapine 100 MG Oral Tablet [Seroquel]SBD8ae62aaf-f8c5-417f-baac-0098369ca32253
153640quetiapine 200 MG Oral Tablet [Seroquel]SBD8ae62aaf-f8c5-417f-baac-0098369ca32253
153638quetiapine 25 MG Oral Tablet [Seroquel]SBD8ae62aaf-f8c5-417f-baac-0098369ca32253
284509quetiapine 300 MG Oral Tablet [Seroquel]SBD8ae62aaf-f8c5-417f-baac-0098369ca32253
616485quetiapine 400 MG Oral Tablet [Seroquel]SBD8ae62aaf-f8c5-417f-baac-0098369ca32253
616489quetiapine 50 MG Oral Tablet [Seroquel]SBD8ae62aaf-f8c5-417f-baac-0098369ca32253
312743quetiapine 100 MG Oral TabletSCD8ae62aaf-f8c5-417f-baac-0098369ca32253
317174quetiapine 200 MG Oral TabletSCD8ae62aaf-f8c5-417f-baac-0098369ca32253
312744quetiapine 25 MG Oral TabletSCD8ae62aaf-f8c5-417f-baac-0098369ca32253
312745quetiapine 300 MG Oral TabletSCD8ae62aaf-f8c5-417f-baac-0098369ca32253
616483quetiapine 400 MG Oral TabletSCD8ae62aaf-f8c5-417f-baac-0098369ca32253
616487quetiapine 50 MG Oral TabletSCD8ae62aaf-f8c5-417f-baac-0098369ca32253
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
153639Seroquel 100 MG (as quetiapine fumarate) Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
153639Seroquel 100 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
153640Seroquel 200 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
153638Seroquel 25 MG (as quetiapine fumarate) Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
153638Seroquel 25 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
284509Seroquel 300 MG (as quetiapine fumarate) Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
284509Seroquel 300 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
616485Seroquel 400 MG (as quetiapine fumarate) Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
616485Seroquel 400 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
616489Seroquel 50 MG (as quetiapine fumarate) Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253
616489Seroquel 50 MG Oral TabletSY8ae62aaf-f8c5-417f-baac-0098369ca32253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61269-254-606126902546060 TABLET, FILM COATED in 1 BOTTLE (61269-254-60) 2000-11-13NoNoHistorical