FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
67046-174
11-digit product format
670460174
Labeler code
67046
Product ID
67046-174_5a05b94a-6dda-572e-e053-2a91aa0a660f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090939
Marketing category
ANDA
Marketing start
2017-09-25
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
2020-12-31
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
67046-174-072022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-142022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-152022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-202022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-212022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-282022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-302022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002
67046-174-602022-01-28C16284748780-1d6a99b39-33ed-a426-e053-dadaa90af4c2174 Escitalopram 20 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 USP, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-174-07escitalopram oxalate7 in 1 BLISTER PACKTABLET71
67046-174-14escitalopram oxalate14 in 1 BLISTER PACKTABLET141
67046-174-15escitalopram oxalate15 in 1 BLISTER PACKTABLET151
67046-174-20escitalopram oxalate20 in 1 BLISTER PACKTABLET201
67046-174-21escitalopram oxalate21 in 1 BLISTER PACKTABLET211
67046-174-28escitalopram oxalate28 in 1 BLISTER PACKTABLET281
67046-174-30escitalopram oxalate30 in 1 BLISTER PACKTABLET301
67046-174-60escitalopram oxalate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-174ESCITALOPRAM OXALATE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170926_5a05b94a-6dd9-572e-e053-2a91aa0a660f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN5a05b94a-6dd9-572e-e053-2a91aa0a660f1
351250escitalopram 20 MG Oral TabletSCD5a05b94a-6dd9-572e-e053-2a91aa0a660f1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY5a05b94a-6dd9-572e-e053-2a91aa0a660f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-174-07670460174077 TABLET in 1 BLISTER PACK (67046-174-07) 7 tablet2017-09-250000-00-00NoNoCurrent
67046-174-146704601741414 TABLET in 1 BLISTER PACK (67046-174-14) 14 tablet2017-09-250000-00-00NoNoCurrent
67046-174-156704601741515 TABLET in 1 BLISTER PACK (67046-174-15) 15 tablet2017-09-250000-00-00NoNoCurrent
67046-174-206704601742020 TABLET in 1 BLISTER PACK (67046-174-20) 20 tablet2017-09-250000-00-00NoNoCurrent
67046-174-216704601742121 TABLET in 1 BLISTER PACK (67046-174-21) 21 tablet2017-09-250000-00-00NoNoCurrent
67046-174-286704601742828 TABLET in 1 BLISTER PACK (67046-174-28) 28 tablet2017-09-250000-00-00NoNoCurrent
67046-174-306704601743030 TABLET in 1 BLISTER PACK (67046-174-30) 30 tablet2017-09-250000-00-00NoNoCurrent
67046-174-606704601746060 TABLET in 1 BLISTER PACK (67046-174-60) 60 tablet2017-09-250000-00-00NoNoCurrent