FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
71335-2428
11-digit product format
713352428
Labeler code
71335
Product ID
71335-2428_4c5fc0a3-3bf8-4050-86d2-320d90534262
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
100 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 FUMARATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743

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
71335-2428-1Quetiapine fumarate100 in 1 BOTTLETABLET1002
71335-2428-2Quetiapine fumarate30 in 1 BOTTLETABLET302
71335-2428-3Quetiapine fumarate120 in 1 BOTTLETABLET1202
71335-2428-4Quetiapine fumarate60 in 1 BOTTLETABLET602
71335-2428-5Quetiapine fumarate90 in 1 BOTTLETABLET902
71335-2428-6Quetiapine fumarate15 in 1 BOTTLETABLET152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2428-2EA - Each71335-2428649c19c8-9a7a-476f-a90d-f25dee4800f312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2428QUETIAPINE FUMARATE TABLET [BRYANT RANCH PREPACK]2Current NDC, 6 package rows20250227_385f7c3d-3299-4b04-947e-de2ee78c8241.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN385f7c3d-3299-4b04-947e-de2ee78c82412
312743quetiapine 100 MG Oral TabletSCD385f7c3d-3299-4b04-947e-de2ee78c82412
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY385f7c3d-3299-4b04-947e-de2ee78c82412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2428-171335242801100 TABLET in 1 BOTTLE (71335-2428-1) 100 tablet2025-01-31NoNoCurrent
71335-2428-27133524280230 TABLET in 1 BOTTLE (71335-2428-2) 30 tablet2024-10-01NoNoCurrent
71335-2428-371335242803120 TABLET in 1 BOTTLE (71335-2428-3) 120 tablet2025-01-31NoNoCurrent
71335-2428-47133524280460 TABLET in 1 BOTTLE (71335-2428-4) 60 tablet2025-01-31NoNoCurrent
71335-2428-57133524280590 TABLET in 1 BOTTLE (71335-2428-5) 90 tablet2025-01-31NoNoCurrent
71335-2428-67133524280615 TABLET in 1 BOTTLE (71335-2428-6) 15 tablet2025-01-31NoNoCurrent