FDA.reportPublic FDA data

Escitalopram

Product NDC
67046-171
11-digit product format
670460171
Labeler code
67046
Product ID
67046-171_5a084ea4-cafd-ffed-e053-2991aa0aa0d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076765
Marketing category
ANDA
Marketing start
2017-09-25
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
2019-12-31
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
67046-171-072020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-142020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-152020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-202020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-212020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-282020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-302020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-602020-01-31C16284748780-19d75b9d0-e4e5-f424-e053-dadaa90a57ce171 Escitalopram 10 mg These 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
67046-171-07Escitalopram7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-171-14Escitalopram14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-171-15Escitalopram15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-171-20Escitalopram20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-171-21Escitalopram21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-171-28Escitalopram28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-171-30Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-171-60Escitalopram60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-171ESCITALOPRAM TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170925_5a084ea4-cafc-ffed-e053-2991aa0aa0d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN5a084ea4-cafc-ffed-e053-2991aa0aa0d91
349332escitalopram 10 MG Oral TabletSCD5a084ea4-cafc-ffed-e053-2991aa0aa0d91
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY5a084ea4-cafc-ffed-e053-2991aa0aa0d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-171-07670460171077 in 1 BLISTER PACKHistorical
67046-171-146704601711414 in 1 BLISTER PACKHistorical
67046-171-156704601711515 in 1 BLISTER PACKHistorical
67046-171-206704601712020 in 1 BLISTER PACKHistorical
67046-171-216704601712121 in 1 BLISTER PACKHistorical
67046-171-286704601712828 in 1 BLISTER PACKHistorical
67046-171-306704601713030 in 1 BLISTER PACKHistorical
67046-171-606704601716060 in 1 BLISTER PACKHistorical