FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
71335-2278
11-digit product format
713352278
Labeler code
71335
Product ID
71335-2278_02532cff-d88a-46d9-88d1-4a028ba5051d
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
300 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 FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312745

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
71335-2278-1Quetiapine fumarate30 in 1 BOTTLETABLET30102
71335-2278-2Quetiapine fumarate60 in 1 BOTTLETABLET60102
71335-2278-3Quetiapine fumarate28 in 1 BOTTLETABLET28102
71335-2278-4Quetiapine fumarate90 in 1 BOTTLETABLET90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2278-1EA - Each71335-22780ccc27ca-2356-45e7-845e-bd1ef607a0e712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2278QUETIAPINE FUMARATE TABLET [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20250228_94a81681-381e-4b3b-89ac-e86dcbe7f890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312745QUEtiapine fumarate 300 MG Oral TabletPSN94a81681-381e-4b3b-89ac-e86dcbe7f890102
312745quetiapine 300 MG Oral TabletSCD94a81681-381e-4b3b-89ac-e86dcbe7f890102
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY94a81681-381e-4b3b-89ac-e86dcbe7f890102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2278-17133522780130 TABLET in 1 BOTTLE (71335-2278-1) 30 tablet2023-11-09NoNoHistorical
71335-2278-27133522780260 TABLET in 1 BOTTLE (71335-2278-2) 60 tablet2025-01-31NoNoHistorical
71335-2278-37133522780328 TABLET in 1 BOTTLE (71335-2278-3) 28 tablet2025-01-31NoNoHistorical
71335-2278-47133522780490 TABLET in 1 BOTTLE (71335-2278-4) 90 tablet2025-01-31NoNoHistorical