FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
71335-2176
11-digit product format
713352176
Labeler code
71335
Product ID
71335-2176_35073226-49ae-4460-e063-6294a90a54cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201190
Marketing category
ANDA
Marketing start
2012-03-28
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2176-1Quetiapine fumarate30 in 1 BOTTLETABLET, FILM COATED30103
71335-2176-2Quetiapine fumarate60 in 1 BOTTLETABLET, FILM COATED60103
71335-2176-3Quetiapine fumarate90 in 1 BOTTLETABLET, FILM COATED90103
71335-2176-4Quetiapine fumarate25 in 1 BOTTLETABLET, FILM COATED25103
71335-2176-5Quetiapine fumarate120 in 1 BOTTLETABLET, FILM COATED120103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2176QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20250515_3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSN3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2103
616487quetiapine 50 MG Oral TabletSCD3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2103
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2176-17133521760130 TABLET, FILM COATED in 1 BOTTLE (71335-2176-1) 2022-10-100000-00-00NoNoCurrent
71335-2176-27133521760260 TABLET, FILM COATED in 1 BOTTLE (71335-2176-2) 2022-10-170000-00-00NoNoCurrent
71335-2176-37133521760390 TABLET, FILM COATED in 1 BOTTLE (71335-2176-3) 2024-04-030000-00-00NoNoCurrent
71335-2176-47133521760425 TABLET, FILM COATED in 1 BOTTLE (71335-2176-4) 2024-04-030000-00-00NoNoCurrent
71335-2176-571335217605120 TABLET, FILM COATED in 1 BOTTLE (71335-2176-5) 2024-04-030000-00-00NoNoCurrent