FDA.reportPublic FDA data

Quetiapine

Product NDC
0904-6801
11-digit product format
009046801
Labeler code
0904
Product ID
0904-6801_3d4de1de-a8d2-4cd6-b9a6-d38e2d009df7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204203
Marketing category
ANDA
Marketing start
2017-08-22
Substance
QUETIAPINE FUMARATE
Active strength
50 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 FUMARATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 853201, 895670

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
0904-6801-61Quetiapine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE19
0904-6801-61Quetiapine100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6801-61EA - Each0904-6801e018730a-54ee-400a-83e5-792db98534e312019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6801QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20240823_b02324b1-e7f0-4cbc-8778-5f7c4a5d194a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6801-6100904680161100 BLISTER PACK in 1 CARTON (0904-6801-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2017-08-220000-00-00NoNoCurrent