FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
16571-809
11-digit product format
165710809
Labeler code
16571
Product ID
16571-809_b7aef4ea-0c7d-496f-b567-613189147c7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA091388
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
150 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 FUMARATE150 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
16571-809-01Quetiapine Fumarate100 in 1 BOTTLETABLET, FILM COATED1007
16571-809-10Quetiapine Fumarate1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-809-01EA - Each16571-809f6a21871-05d7-4d15-a940-955cda6ca22012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-809QUETIAPINE FUMARATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 2 package rows20250427_532c8ace-4cf5-4a08-bae7-2af8c41ffa3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
389201QUEtiapine fumarate 150 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
317174QUEtiapine fumarate 200 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312744QUEtiapine fumarate 25 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312745QUEtiapine fumarate 300 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
616483QUEtiapine fumarate 400 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
616487QUEtiapine fumarate 50 MG Oral TabletPSN532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312743quetiapine 100 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
389201quetiapine 150 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
317174quetiapine 200 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312744quetiapine 25 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312745quetiapine 300 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
616483quetiapine 400 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
616487quetiapine 50 MG Oral TabletSCD532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
389201quetiapine (as quetiapine fumarate) 150 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY532c8ace-4cf5-4a08-bae7-2af8c41ffa3d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-809-0116571080901100 TABLET, FILM COATED in 1 BOTTLE (16571-809-01) 2012-03-270000-00-00NoNoCurrent
16571-809-10165710809101000 TABLET, FILM COATED in 1 BOTTLE (16571-809-10) 2012-03-270000-00-00NoNoCurrent