FDA.reportPublic FDA data

QUETIAPINE FUMARATE

Product NDC
50090-5442
11-digit product format
500905442
Labeler code
50090
Product ID
50090-5442_6a0bc8f8-d8f8-44e2-b714-ce0c0be32916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090681
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
300 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5442-02023-01-30C16284748780-1f386c649-c9e0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE extended-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5442-0QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5442QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210304_1e2d5b10-3e07-4690-b06f-13e738a17972.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN1e2d5b10-3e07-4690-b06f-13e738a179721
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD1e2d5b10-3e07-4690-b06f-13e738a179721
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY1e2d5b10-3e07-4690-b06f-13e738a179721
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY1e2d5b10-3e07-4690-b06f-13e738a179721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5442-05009054420060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5442-0) 2021-01-210000-00-00NoNoCurrent