FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
68071-3312
11-digit product format
680713312
Labeler code
68071
Product ID
68071-3312_5163a2ab-772c-69a6-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA090939
Marketing category
ANDA
Marketing start
2012-09-11
Marketing end
0000-00-00
Substance
ESCITALOPRAM OXALATE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
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
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3312-32020-01-31C16284748780-19d75b9cf-fe93-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
68071-3312-82020-01-31C16284748780-19d75b9cf-fe93-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
68071-3312-3escitalopram oxalate30 in 1 BOTTLETABLET301
68071-3312-8escitalopram oxalate28 in 1 BOTTLETABLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3312ESCITALOPRAM OXALATE TABLET [NUCARE PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20170607_5163a9cf-5ab7-592c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN5163a9cf-5ab7-592c-e054-00144ff88e881
351250escitalopram 20 MG Oral TabletSCD5163a9cf-5ab7-592c-e054-00144ff88e881
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY5163a9cf-5ab7-592c-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68071-3312-36807133120330 in 1 BOTTLEHistorical
68071-3312-86807133120828 in 1 BOTTLEHistorical