FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
71335-2691
11-digit product format
713352691
Labeler code
71335
Product ID
71335-2691_7a252c30-579a-4198-bce3-f201e98e78b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091388
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine Fumarate
Listing expiration
2027-12-31

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
71335-2691-1Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED302
71335-2691-2Quetiapine Fumarate60 in 1 BOTTLETABLET, FILM COATED602
71335-2691-3Quetiapine Fumarate90 in 1 BOTTLETABLET, FILM COATED902
71335-2691-4Quetiapine Fumarate25 in 1 BOTTLETABLET, FILM COATED252
71335-2691-5Quetiapine Fumarate120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNd3dcfb51-e67d-44dc-9186-4729f6414bf12
616487quetiapine 50 MG Oral TabletSCDd3dcfb51-e67d-44dc-9186-4729f6414bf12
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYd3dcfb51-e67d-44dc-9186-4729f6414bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2691-17133526910130 TABLET, FILM COATED in 1 BOTTLE (71335-2691-1) 2025-09-18NoNoHistorical
71335-2691-27133526910260 TABLET, FILM COATED in 1 BOTTLE (71335-2691-2) 2025-09-18NoNoHistorical
71335-2691-37133526910390 TABLET, FILM COATED in 1 BOTTLE (71335-2691-3) 2025-09-18NoNoHistorical
71335-2691-47133526910425 TABLET, FILM COATED in 1 BOTTLE (71335-2691-4) 2025-09-18NoNoHistorical
71335-2691-571335269105120 TABLET, FILM COATED in 1 BOTTLE (71335-2691-5) 2025-09-18NoNoHistorical