FDA.reportPublic FDA data

quetiapine fumarate

Product NDC
43353-161
11-digit product format
433530161
Labeler code
43353
Product ID
43353-161_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090960
Marketing category
ANDA
Marketing start
2015-07-21
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
200 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-161-302020-01-31C16284748780-19d75b9d0-e1b5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
43353-161-532020-01-31C16284748780-19d75b9d0-e1b5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-161-30quetiapine fumarate30 in 1 BOTTLETABLET, FILM COATED301
43353-161-53quetiapine fumarate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-161-30EA - Each43353-16131e68cc0-0543-4cd5-a87c-6282e1bbe67412016-07-19
43353-161-53EA - Each43353-161496a39cc-12b4-480d-b58d-87d16f55f53312016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-161QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20160713_448cbd68-ab4f-447c-8e47-0f874fb5bcb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN448cbd68-ab4f-447c-8e47-0f874fb5bcb41
317174QUEtiapine fumarate 200 MG Oral TabletPSN448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312744QUEtiapine fumarate 25 MG Oral TabletPSN448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312745QUEtiapine fumarate 300 MG Oral TabletPSN448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312743quetiapine 100 MG Oral TabletSCD448cbd68-ab4f-447c-8e47-0f874fb5bcb41
317174quetiapine 200 MG Oral TabletSCD448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312744quetiapine 25 MG Oral TabletSCD448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312745quetiapine 300 MG Oral TabletSCD448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY448cbd68-ab4f-447c-8e47-0f874fb5bcb41
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY448cbd68-ab4f-447c-8e47-0f874fb5bcb41
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY448cbd68-ab4f-447c-8e47-0f874fb5bcb41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-161-304335301613030 in 1 BOTTLEHistorical
43353-161-534335301615360 in 1 BOTTLEHistorical