Quetiapine Fumarate

Product NDC
50090-3379
11-digit product format
500903379
Labeler code
50090
Product ID
50090-3379_48fb8dd5-a13e-4c10-a05b-7592e2de638f
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3379-0Quetiapine Fumarate33 in 1 BOTTLETABLET, FILM COATED331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3379QUETIAPINE FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190205_0c429a53-9e3a-4463-8f86-4a596dd8ac18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN0c429a53-9e3a-4463-8f86-4a596dd8ac181
317174quetiapine 200 MG Oral TabletSCD0c429a53-9e3a-4463-8f86-4a596dd8ac181
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY0c429a53-9e3a-4463-8f86-4a596dd8ac181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3379-05009033790033 TABLET, FILM COATED in 1 BOTTLE (50090-3379-0) 2018-02-220000-00-00NoNoCurrent