Quetiapine Fumarate

Product NDC
50090-4022
11-digit product format
500904022
Labeler code
50090
Product ID
50090-4022_5c85eaeb-2f0f-4255-ba33-dccb7bbbda9c
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
50 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4022-0Quetiapine Fumarate60 in 1 BOTTLETABLET, FILM COATED607
50090-4022-1Quetiapine Fumarate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4022QUETIAPINE FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20210417_77c30344-4e92-4370-b6a0-e93082755f88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSN77c30344-4e92-4370-b6a0-e93082755f887
616487quetiapine 50 MG Oral TabletSCD77c30344-4e92-4370-b6a0-e93082755f887
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY77c30344-4e92-4370-b6a0-e93082755f887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4022-05009040220060 TABLET, FILM COATED in 1 BOTTLE (50090-4022-0) 2019-01-070000-00-00NoNoCurrent
50090-4022-15009040220130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4022-1) 2016-07-010000-00-00NoNoCurrent