FDA.reportPublic FDA data

Escitalopram

Product NDC
71335-1571
11-digit product format
713351571
Labeler code
71335
Product ID
71335-1571_c6523723-999b-481e-a9d7-8610a4d30ccb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078032
Marketing category
ANDA
Marketing start
2012-03-15
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
No
Listing certified through
2023-12-31
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
71335-1571-12024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-22024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-32024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-42024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-52024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-62024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-72024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-82024-01-30C16284748780-11030e365-28d6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1571-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED309
71335-1571-2Escitalopram28 in 1 BOTTLETABLET, FILM COATED289
71335-1571-3Escitalopram60 in 1 BOTTLETABLET, FILM COATED609
71335-1571-4Escitalopram90 in 1 BOTTLETABLET, FILM COATED909
71335-1571-5Escitalopram10 in 1 BOTTLETABLET, FILM COATED109
71335-1571-6Escitalopram120 in 1 BOTTLETABLET, FILM COATED1209
71335-1571-7Escitalopram7 in 1 BOTTLETABLET, FILM COATED79
71335-1571-8Escitalopram180 in 1 BOTTLETABLET, FILM COATED1809

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1571ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]9Legacy NDC, 8 package rows20220211_d96efcdf-88ac-4153-9a38-4cd47e5bbb5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNd96efcdf-88ac-4153-9a38-4cd47e5bbb5b9
349332escitalopram 10 MG Oral TabletSCDd96efcdf-88ac-4153-9a38-4cd47e5bbb5b9
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd96efcdf-88ac-4153-9a38-4cd47e5bbb5b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1571-17133515710130 TABLET, FILM COATED in 1 BOTTLE (71335-1571-1) 2012-03-150000-00-00NoNoCurrent
71335-1571-27133515710228 TABLET, FILM COATED in 1 BOTTLE (71335-1571-2) 2012-03-150000-00-00NoNoCurrent
71335-1571-37133515710360 TABLET, FILM COATED in 1 BOTTLE (71335-1571-3) 2012-03-150000-00-00NoNoCurrent
71335-1571-47133515710490 TABLET, FILM COATED in 1 BOTTLE (71335-1571-4) 2012-03-150000-00-00NoNoCurrent
71335-1571-57133515710510 TABLET, FILM COATED in 1 BOTTLE (71335-1571-5) 2012-03-150000-00-00NoNoCurrent
71335-1571-671335157106120 TABLET, FILM COATED in 1 BOTTLE (71335-1571-6) 2012-03-150000-00-00NoNoCurrent
71335-1571-7713351571077 TABLET, FILM COATED in 1 BOTTLE (71335-1571-7) 2012-03-150000-00-00NoNoCurrent
71335-1571-871335157108180 TABLET, FILM COATED in 1 BOTTLE (71335-1571-8) 2022-02-100000-00-00NoNoCurrent