FDA.reportPublic FDA data

SEROQUEL

Product NDC
61269-270
11-digit product format
612690270
Labeler code
61269
Product ID
61269-270_30d64c02-e070-43b8-9c96-3f7b112c5f7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H2-Pharma, LLC
Application
NDA022047
Marketing category
NDA
Marketing start
2009-02-01
Substance
QUETIAPINE FUMARATE
Active strength
50 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
Brand name suffix
XR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE50 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-270-60SEROQUELXR60 in 1 BOTTLETABLET, EXTENDED RELEASE6050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-270-60EA - Each61269-270b93fb766-4de4-4603-b605-c0042f50221912026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-270SEROQUEL XR (QUETIAPINE) TABLET, EXTENDED RELEASE [H2-PHARMA, LLC]48Current NDC, 1 package rows20250416_ab959a35-d0ba-4f18-8f2e-6619d88b16e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
895671SEROQUEL XR 150 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
721793SEROQUEL XR 200 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
721797SEROQUEL XR 400 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
853202SEROQUEL XR 50 MG 24HR Extended Release Oral TabletPSNab959a35-d0ba-4f18-8f2e-6619d88b16e350
89567124 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]SBDab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179324 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]SBDab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179524 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]SBDab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179724 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]SBDab959a35-d0ba-4f18-8f2e-6619d88b16e350
85320224 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]SBDab959a35-d0ba-4f18-8f2e-6619d88b16e350
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDab959a35-d0ba-4f18-8f2e-6619d88b16e350
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCDab959a35-d0ba-4f18-8f2e-6619d88b16e350
89567124 HR Seroquel 150 MG Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179324 HR Seroquel 200 MG Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179524 HR Seroquel 300 MG Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
72179724 HR Seroquel 400 MG Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
85320224 HR Seroquel 50 MG Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
895671Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721793Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721795Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
721797Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350
853202Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSYab959a35-d0ba-4f18-8f2e-6619d88b16e350

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61269-270-606126902706060 TABLET, EXTENDED RELEASE in 1 BOTTLE (61269-270-60) 2009-02-01NoNoCurrent