FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50090-3377
11-digit product format
500903377
Labeler code
50090
Product ID
50090-3377_58a25b01-535d-4257-bb96-7133f6663879
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
Substance
QUETIAPINE FUMARATE
Active strength
100 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 FUMARATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 317174

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
50090-3377-02024-04-03C16284748780-1f386c649-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
50090-3377-12024-04-03C16284748780-1f386c649-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
50090-3377-02023-01-30C16284748780-1f386c649-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
50090-3377-12023-01-30C16284748780-1f386c649-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
50090-3377-0Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED3011
50090-3377-1Quetiapine Fumarate90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3377QUETIAPINE FUMARATE TABLET, FILM COATED QUETIAPINE FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 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
50090-3377-05009033770030 TABLET, FILM COATED in 1 BOTTLE (50090-3377-0) 2018-02-210000-00-00NoNoCurrent
50090-3377-15009033770190 TABLET, FILM COATED in 1 BOTTLE (50090-3377-1) 2018-05-150000-00-00NoNoCurrent