FDA.reportPublic FDA data

Escitalopram Oxalate

Product NDC
10544-968
11-digit product format
105440968
Labeler code
10544
Product ID
10544-968_2b9905c8-1bf2-6d8e-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
NDA021323
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-11
Marketing end
0000-00-00
Substance
ESCITALOPRAM OXALATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-968-302020-01-31C16284748780-19d75b9d0-8b33-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use escitalopram tablets safely and effectively. See full prescribing information for escitalopram tablets. ESCITALOPRAM tablets USP, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-968-30Escitalopram Oxalate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-968ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20160213_2b982098-bbdc-472f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2b982098-bbdc-472f-e054-00144ff8d46c2
351250escitalopram oxalate 20 MG Oral TabletPSN2b982098-bbdc-472f-e054-00144ff8d46c2
349332escitalopram 10 MG Oral TabletSCD2b982098-bbdc-472f-e054-00144ff8d46c2
351250escitalopram 20 MG Oral TabletSCD2b982098-bbdc-472f-e054-00144ff8d46c2
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2b982098-bbdc-472f-e054-00144ff8d46c2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2b982098-bbdc-472f-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-968-301054409683030 in 1 BOTTLE, PLASTICHistorical