FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50090-3303
11-digit product format
500903303
Labeler code
50090
Product ID
50090-3303_3ae31705-5251-491d-87b8-27eb40f27959
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202674
Marketing category
ANDA
Marketing start
2016-07-01
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
2022-12-31
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
50090-3303-02024-04-03C16284748780-1f386c649-cecd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
50090-3303-02023-01-30C16284748780-1f386c649-cecd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3303-0Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3303QUETIAPINE FUMARATE TABLET, FILM COATED QUETIAPINE FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Legacy NDC, 1 package rows20240405_845159aa-1ac2-41b7-ac21-d4b03e43203b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN845159aa-1ac2-41b7-ac21-d4b03e43203b11
317174QUEtiapine fumarate 200 MG Oral TabletPSN845159aa-1ac2-41b7-ac21-d4b03e43203b11
312743quetiapine 100 MG Oral TabletSCD845159aa-1ac2-41b7-ac21-d4b03e43203b11
317174quetiapine 200 MG Oral TabletSCD845159aa-1ac2-41b7-ac21-d4b03e43203b11
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY845159aa-1ac2-41b7-ac21-d4b03e43203b11
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY845159aa-1ac2-41b7-ac21-d4b03e43203b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3303-05009033030030 TABLET, FILM COATED in 1 BOTTLE (50090-3303-0) 2017-12-150000-00-00NoNoCurrent