FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
68151-5225
11-digit product format
681515225
Labeler code
68151
Product ID
68151-5225_f5ea0edd-30f5-41cb-9623-d9a93f4abead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA206260
Marketing category
ANDA
Marketing start
2017-05-10
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
50 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-5225-12020-01-31C16284748780-19d75b9d1-1e9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS. QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE for ORAL use. Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5225-1Quetiapine Fumarate1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5225QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20171228_245f426a-f1b5-4641-8ada-aae02da3ee59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN245f426a-f1b5-4641-8ada-aae02da3ee592
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD245f426a-f1b5-4641-8ada-aae02da3ee592
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY245f426a-f1b5-4641-8ada-aae02da3ee592
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY245f426a-f1b5-4641-8ada-aae02da3ee592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5225-1681515225011 in 1 BLISTER PACKHistorical