FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
71335-2422
11-digit product format
713352422
Labeler code
71335
Product ID
71335-2422_2c265ca9-dd7f-493f-be8b-fc9785263fbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201109
Marketing category
ANDA
Marketing start
2012-03-27
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 fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui616487

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
71335-2422-1Quetiapine fumarate30 in 1 BOTTLETABLET302
71335-2422-2Quetiapine fumarate60 in 1 BOTTLETABLET602
71335-2422-3Quetiapine fumarate90 in 1 BOTTLETABLET902
71335-2422-4Quetiapine fumarate25 in 1 BOTTLETABLET252
71335-2422-5Quetiapine fumarate120 in 1 BOTTLETABLET1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2422QUETIAPINE FUMARATE TABLET [BRYANT RANCH PREPACK]2Current NDC, 5 package rows20250216_fd9cce28-0052-4b0b-8a66-a1615e082d95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNfd9cce28-0052-4b0b-8a66-a1615e082d952
616487quetiapine 50 MG Oral TabletSCDfd9cce28-0052-4b0b-8a66-a1615e082d952
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYfd9cce28-0052-4b0b-8a66-a1615e082d952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2422-17133524220130 TABLET in 1 BOTTLE (71335-2422-1) 30 tablet2024-07-01NoNoCurrent
71335-2422-27133524220260 TABLET in 1 BOTTLE (71335-2422-2) 60 tablet2024-07-01NoNoCurrent
71335-2422-37133524220390 TABLET in 1 BOTTLE (71335-2422-3) 90 tablet2024-07-01NoNoCurrent
71335-2422-47133524220425 TABLET in 1 BOTTLE (71335-2422-4) 25 tablet2024-07-01NoNoCurrent
71335-2422-571335242205120 TABLET in 1 BOTTLE (71335-2422-5) 120 tablet2024-07-01NoNoCurrent