FDA.reportPublic FDA data

Quetiapine

Product NDC
16729-149
11-digit product format
167290149
Labeler code
16729
Product ID
16729-149_438f950d-730b-8926-e063-6294a90a8f66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
Substance
QUETIAPINE FUMARATE
Active strength
300 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 312744, 312745, 317174, 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
16729-149-00Quetiapine100 in 1 BOTTLETABLET, FILM COATED10017
16729-149-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10017
16729-149-10Quetiapine30 in 1 BOTTLETABLET, FILM COATED3017
16729-149-12Quetiapine60 in 1 BOTTLETABLET, FILM COATED6017
16729-149-17Quetiapine1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-149QUETIAPINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]16Current NDC, Legacy NDC, 5 package rows20240719_2d77412a-e084-4406-ac33-d882aece9354.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
317174QUEtiapine fumarate 200 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312744QUEtiapine fumarate 25 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312745QUEtiapine fumarate 300 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
616483QUEtiapine fumarate 400 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
616487QUEtiapine fumarate 50 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312743quetiapine 100 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
317174quetiapine 200 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312744quetiapine 25 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312745quetiapine 300 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
616483quetiapine 400 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
616487quetiapine 50 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312745QUEtiapine fumarate 300 MG Oral TabletPSN8e91aeae-92fd-49a7-b171-42abbd7d774a8
312745quetiapine 300 MG Oral TabletSCD8e91aeae-92fd-49a7-b171-42abbd7d774a8
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY8e91aeae-92fd-49a7-b171-42abbd7d774a8
312743QUEtiapine fumarate 100 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174QUEtiapine fumarate 200 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745QUEtiapine fumarate 300 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine 100 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine 200 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine 300 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-149-0016729014900100 in 1 BOTTLEHistorical
16729-149-0116729014901100 TABLET, FILM COATED in 1 BOTTLE (16729-149-01) 2015-11-020000-00-00NoNoCurrent
16729-149-101672901491030 TABLET, FILM COATED in 1 BOTTLE (16729-149-10) 2012-03-280000-00-00NoNoCurrent
16729-149-121672901491260 TABLET, FILM COATED in 1 BOTTLE (16729-149-12) 2012-03-280000-00-00NoNoCurrent
16729-149-17167290149171000 TABLET, FILM COATED in 1 BOTTLE (16729-149-17) 2012-03-280000-00-00NoNoCurrent
16729-149-18167290149182000 TABLET, FILM COATED in 1 CONTAINER (16729-149-18)16-DEC-15Current