FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
65862-495
11-digit product format
658620495
Labeler code
65862
Product ID
65862-495_f759dcc0-2e6c-4743-8772-3f05602db2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA091388
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
400 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 FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 312744, 312745, 317174, 389201, 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
65862-495-01Quetiapine Fumarate100 in 1 BOTTLETABLET, FILM COATED10019
65862-495-05Quetiapine Fumarate500 in 1 BOTTLETABLET, FILM COATED50019
65862-495-10Quetiapine Fumarate10 in 1 CARTONTABLET, FILM COATED1019
65862-495-10Quetiapine Fumarate10 in 1 BLISTER PACKTABLET, FILM COATED1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-495QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]18Current NDC, Legacy NDC, 4 package rows20250308_8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
389201QUEtiapine fumarate 150 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
317174QUEtiapine fumarate 200 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312744QUEtiapine fumarate 25 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312745QUEtiapine fumarate 300 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616483QUEtiapine fumarate 400 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616487QUEtiapine fumarate 50 MG Oral TabletPSN8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312743quetiapine 100 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
389201quetiapine 150 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
317174quetiapine 200 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312744quetiapine 25 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312745quetiapine 300 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616483quetiapine 400 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616487quetiapine 50 MG Oral TabletSCD8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
389201quetiapine (as quetiapine fumarate) 150 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b619
616483QUEtiapine fumarate 400 MG Oral TabletPSNb90390d8-6ebc-48b3-8b4d-6a3ff7d19ef64
616483quetiapine 400 MG Oral TabletSCDb90390d8-6ebc-48b3-8b4d-6a3ff7d19ef64
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYb90390d8-6ebc-48b3-8b4d-6a3ff7d19ef64
616483QUEtiapine fumarate 400 MG Oral TabletPSN55018271-1f8f-4683-afee-8203c3bd9acc3
616483quetiapine 400 MG Oral TabletSCD55018271-1f8f-4683-afee-8203c3bd9acc3
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY55018271-1f8f-4683-afee-8203c3bd9acc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-495-0165862049501100 TABLET, FILM COATED in 1 BOTTLE (65862-495-01) 2012-03-270000-00-00NoNoCurrent
65862-495-0565862049505500 TABLET, FILM COATED in 1 BOTTLE (65862-495-05) 2012-03-270000-00-00NoNoCurrent
65862-495-106586204951010 BLISTER PACK in 1 CARTON (65862-495-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-03-270000-00-00NoNoCurrent
65862-495-15658620495151500 TABLET, FILM COATED in 1 BAG (65862-495-15)27-MAR-12Current