FDA.reportPublic FDA data

Quetiapine

Product NDC
71610-538
11-digit product format
716100538
Labeler code
71610
Product ID
71610-538_d1df9607-4b6b-46e9-99c9-821ba0deee76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077745
Marketing category
ANDA
Marketing start
2012-03-27
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
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
71610-538-872023-01-30C16284748780-1f386c64a-0306-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-538-87Quetiapine2400 in 1 BOTTLETABLET, FILM COATED24001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-538-87EA - Each71610-538e12ef59a-1197-401b-b2da-e5092794a83812021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-538QUETIAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20210424_0305fd0e-7a5c-4386-b020-2d70e9542dc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616483QUEtiapine fumarate 400 MG Oral TabletPSN0305fd0e-7a5c-4386-b020-2d70e9542dc11
616483quetiapine 400 MG Oral TabletSCD0305fd0e-7a5c-4386-b020-2d70e9542dc11
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY0305fd0e-7a5c-4386-b020-2d70e9542dc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-538-87716100538872400 TABLET, FILM COATED in 1 BOTTLE (71610-538-87) 2021-04-070000-00-00NoNoCurrent