escitalopram oxalate

Product NDC
68071-3265
11-digit product format
680713265
Labeler code
68071
Product ID
68071-3265_e11b27ab-5a2b-76c4-e053-2a95a90a7293
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
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
68071-3265-22025-01-30C16284748780-19d75b9d0-828d-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
68071-3265-32025-01-30C16284748780-19d75b9d0-828d-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
68071-3265-92025-01-30C16284748780-19d75b9d0-828d-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
68071-3265-22020-07-21C16284748780-19d75b9d0-828d-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
68071-3265-32020-07-21C16284748780-19d75b9d0-828d-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
68071-3265-92020-07-21C16284748780-19d75b9d0-828d-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
68071-3265-22020-01-31C16284748780-19d75b9d0-828d-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
68071-3265-32020-01-31C16284748780-19d75b9d0-828d-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
68071-3265-92020-01-31C16284748780-19d75b9d0-828d-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
68071-3265-2escitalopram oxalate20 in 1 BOTTLETABLET204
68071-3265-3escitalopram oxalate30 in 1 BOTTLETABLET304
68071-3265-9escitalopram oxalate90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3265ESCITALOPRAM OXALATE TABLET [NUCARE PHARMACEUTICALS, INC.]4Legacy NDC, 3 package rows20220612_4f434cbc-318b-6554-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN4f434cbc-318b-6554-e054-00144ff88e884
349332escitalopram 10 MG Oral TabletSCD4f434cbc-318b-6554-e054-00144ff88e884
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY4f434cbc-318b-6554-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3265-26807132650220 TABLET in 1 BOTTLE (68071-3265-2) 20 tablet2017-05-110000-00-00NoNoCurrent
68071-3265-36807132650330 TABLET in 1 BOTTLE (68071-3265-3) 30 tablet2017-05-110000-00-00NoNoCurrent
68071-3265-96807132650990 TABLET in 1 BOTTLE (68071-3265-9) 90 tablet2017-05-110000-00-00NoNoCurrent