FDA.reportPublic FDA data

Escitalopram

Product NDC
53002-1453
11-digit product format
530021453
Labeler code
53002
Product ID
53002-1453_6b2fd26a-b9b0-4f5f-b80a-e008da64403d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-21
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
2021-12-31
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
53002-1453-02023-01-30C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-32023-01-30C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-62023-01-30C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-02020-12-15C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-32020-12-15C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-62020-12-15C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-02020-01-31C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-32020-01-31C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002
53002-1453-62020-01-31C16284748780-19d75b9d0-c700-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, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1453-0Escitalopram100 in 1 BOTTLETABLET, FILM COATED1005
53002-1453-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED305
53002-1453-6Escitalopram60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53002-1453-3EA - Each53002-1453650ed73a-08c7-4b36-8296-b0915d5bcb0c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1453ESCITALOPRAM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20201217_7716abd2-5378-4281-8767-57ce890be1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram oxalate 20 MG Oral TabletPSN7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram 10 MG Oral TabletSCD7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram 20 MG Oral TabletSCD7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY7716abd2-5378-4281-8767-57ce890be1d75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1453-053002145300100 TABLET, FILM COATED in 1 BOTTLE (53002-1453-0) 2017-09-010000-00-00NoNoCurrent
53002-1453-35300214530330 TABLET, FILM COATED in 1 BOTTLE (53002-1453-3) 2017-09-010000-00-00NoNoCurrent
53002-1453-65300214530660 TABLET, FILM COATED in 1 BOTTLE (53002-1453-6) 2017-09-010000-00-00NoNoCurrent