FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
50090-5451
11-digit product format
500905451
Labeler code
50090
Product ID
50090-5451_5bde79bf-b7c6-4fbd-a27a-dcd013986d0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207655
Marketing category
ANDA
Marketing start
2017-11-29
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
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5451-02023-01-30C16284748780-1f386c649-d3e6-0266-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
50090-5451-0Quetiapine Fumarate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5451QUETIAPINE FUMARATE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210304_a83f2f2e-0e59-482c-90c8-2fd771f04d74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNa83f2f2e-0e59-482c-90c8-2fd771f04d741
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDa83f2f2e-0e59-482c-90c8-2fd771f04d741
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYa83f2f2e-0e59-482c-90c8-2fd771f04d741
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYa83f2f2e-0e59-482c-90c8-2fd771f04d741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5451-05009054510060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5451-0) 2021-01-250000-00-00NoNoCurrent