FDA.reportPublic FDA data

Escitalopram

Product NDC
68071-2597
11-digit product format
680712597
Labeler code
68071
Product ID
68071-2597_d31fd36d-ac25-7e5f-e053-2a95a90a048e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090432
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
No
Listing certified through
2022-12-31
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
68071-2597-32025-01-30C16284748780-1f386c649-bd6b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
68071-2597-92025-01-30C16284748780-1f386c649-bd6b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
68071-2597-32023-08-03C16284748780-1f386c649-bd6b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
68071-2597-92023-08-03C16284748780-1f386c649-bd6b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
68071-2597-32023-01-30C16284748780-1f386c649-bd6b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
68071-2597-92023-01-30C16284748780-1f386c649-bd6b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2597-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED302
68071-2597-9Escitalopram90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2597ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230804_d31fd978-0700-2188-e053-2a95a90a6354.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNd31fd978-0700-2188-e053-2a95a90a63542
351250escitalopram 20 MG Oral TabletSCDd31fd978-0700-2188-e053-2a95a90a63542
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYd31fd978-0700-2188-e053-2a95a90a63542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2597-36807125970330 TABLET, FILM COATED in 1 BOTTLE (68071-2597-3) 2021-12-140000-00-00NoNoCurrent
68071-2597-96807125970990 TABLET, FILM COATED in 1 BOTTLE (68071-2597-9) 2021-12-140000-00-00NoNoCurrent