FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
71335-0926
11-digit product format
713350926
Labeler code
71335
Product ID
71335-0926_a1e6044d-c14d-4856-83aa-ffbf278458a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0926-1Quetiapine Fumarate30 in 1 BOTTLETABLET3018
71335-0926-2Quetiapine Fumarate60 in 1 BOTTLETABLET6018
71335-0926-3Quetiapine Fumarate90 in 1 BOTTLETABLET9018
71335-0926-4Quetiapine Fumarate25 in 1 BOTTLETABLET2518
71335-0926-5Quetiapine Fumarate120 in 1 BOTTLETABLET12018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0926-2EA - Each71335-0926f466b112-b941-45c4-b935-7a9269ce573e12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0926QUETIAPINE FUMARATE TABLET [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 5 package rows20240830_d779f317-683b-4ec6-a309-1dd54332563f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNd779f317-683b-4ec6-a309-1dd54332563f18
616487quetiapine 50 MG Oral TabletSCDd779f317-683b-4ec6-a309-1dd54332563f18
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYd779f317-683b-4ec6-a309-1dd54332563f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0926-17133509260130 TABLET in 1 BOTTLE (71335-0926-1) 30 tablet2018-10-250000-00-00NoNoCurrent
71335-0926-27133509260260 TABLET in 1 BOTTLE (71335-0926-2) 60 tablet2018-08-160000-00-00NoNoCurrent
71335-0926-37133509260390 TABLET in 1 BOTTLE (71335-0926-3) 90 tablet2020-09-040000-00-00NoNoCurrent
71335-0926-47133509260425 TABLET in 1 BOTTLE (71335-0926-4) 25 tablet2024-04-040000-00-00NoNoCurrent
71335-0926-571335092605120 TABLET in 1 BOTTLE (71335-0926-5) 120 tablet2024-04-040000-00-00NoNoCurrent