Quetiapine Fumarate

Product NDC
50090-3540
11-digit product format
500903540
Labeler code
50090
Product ID
50090-3540_4426d1ff-b180-4754-bfab-077c259df605
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
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-3540-0Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3540QUETIAPINE FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190625_fb10b12a-0017-47a2-9826-e403ac6a77a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616483QUEtiapine fumarate 400 MG Oral TabletPSNfb10b12a-0017-47a2-9826-e403ac6a77a71
616483quetiapine 400 MG Oral TabletSCDfb10b12a-0017-47a2-9826-e403ac6a77a71
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYfb10b12a-0017-47a2-9826-e403ac6a77a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3540-05009035400030 TABLET, FILM COATED in 1 BOTTLE (50090-3540-0) 2018-08-160000-00-00NoNoCurrent