FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50268-631
11-digit product format
502680631
Labeler code
50268
Product ID
50268-631_4614f183-03ad-4459-e063-6294a90a391d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA201504
Marketing category
ANDA
Marketing start
2016-05-26
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
Rxcui312743, 312744, 312745, 317174, 616483, 616487

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
50268-631-11Quetiapine Fumarate1 in 1 BLISTER PACKTABLET18
50268-631-15Quetiapine Fumarate50 in 1 BOXTABLET508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-631-11EA - Each50268-6316b5fb7b1-3d14-4f4b-a837-acddd04ba26c12016-07-19
50268-631-15EA - Each50268-6313eff6f50-0ef4-4a3e-a5ba-de5049cfcf6512016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-631QUETIAPINE FUMARATE TABLET [AVPAK]7Current NDC, Legacy NDC, 2 package rows20250112_6b7d7d2f-a50b-8e21-2de4-ccc102016384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN6b7d7d2f-a50b-8e21-2de4-ccc1020163848
317174QUEtiapine fumarate 200 MG Oral TabletPSN6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312744QUEtiapine fumarate 25 MG Oral TabletPSN6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312745QUEtiapine fumarate 300 MG Oral TabletPSN6b7d7d2f-a50b-8e21-2de4-ccc1020163848
616483QUEtiapine fumarate 400 MG Oral TabletPSN6b7d7d2f-a50b-8e21-2de4-ccc1020163848
616487QUEtiapine fumarate 50 MG Oral TabletPSN6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312743quetiapine 100 MG Oral TabletSCD6b7d7d2f-a50b-8e21-2de4-ccc1020163848
317174quetiapine 200 MG Oral TabletSCD6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312744quetiapine 25 MG Oral TabletSCD6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312745quetiapine 300 MG Oral TabletSCD6b7d7d2f-a50b-8e21-2de4-ccc1020163848
616483quetiapine 400 MG Oral TabletSCD6b7d7d2f-a50b-8e21-2de4-ccc1020163848
616487quetiapine 50 MG Oral TabletSCD6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY6b7d7d2f-a50b-8e21-2de4-ccc1020163848
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY6b7d7d2f-a50b-8e21-2de4-ccc1020163848
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY6b7d7d2f-a50b-8e21-2de4-ccc1020163848
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY6b7d7d2f-a50b-8e21-2de4-ccc1020163848
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY6b7d7d2f-a50b-8e21-2de4-ccc1020163848

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-631-11502680631111 in 1 BLISTER PACKHistorical
50268-631-155026806311550 BLISTER PACK in 1 BOX (50268-631-15) / 1 TABLET in 1 BLISTER PACK (50268-631-11) 50 blister pack2016-05-260000-00-00NoNoCurrent