Escitalopram Oxalate

Product NDC
65162-021
11-digit product format
651620021
Labeler code
65162
Product ID
65162-021_058fe58a-fa86-459a-b79a-ac337913bc7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205619
Marketing category
ANDA
Marketing start
2017-05-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram Oxalate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249, 351250

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-021-03Escitalopram Oxalate30 in 1 BOTTLETABLET, FILM COATED3013
65162-021-09Escitalopram Oxalate90 in 1 BOTTLETABLET, FILM COATED9013
65162-021-11Escitalopram Oxalate1000 in 1 BOTTLETABLET, FILM COATED100013
65162-021-50Escitalopram Oxalate500 in 1 BOTTLETABLET, FILM COATED50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-021ESCITALOPRAM OXALATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 4 package rows20240928_8704d062-fa91-4224-9dec-41664d20ee6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN8704d062-fa91-4224-9dec-41664d20ee6b13
351250escitalopram oxalate 20 MG Oral TabletPSN8704d062-fa91-4224-9dec-41664d20ee6b13
351249escitalopram oxalate 5 MG Oral TabletPSN8704d062-fa91-4224-9dec-41664d20ee6b13
349332escitalopram 10 MG Oral TabletSCD8704d062-fa91-4224-9dec-41664d20ee6b13
351250escitalopram 20 MG Oral TabletSCD8704d062-fa91-4224-9dec-41664d20ee6b13
351249escitalopram 5 MG Oral TabletSCD8704d062-fa91-4224-9dec-41664d20ee6b13
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY8704d062-fa91-4224-9dec-41664d20ee6b13
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY8704d062-fa91-4224-9dec-41664d20ee6b13
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY8704d062-fa91-4224-9dec-41664d20ee6b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-021-036516200210330 TABLET, FILM COATED in 1 BOTTLE (65162-021-03) 2017-05-170000-00-00NoNoCurrent
65162-021-096516200210990 TABLET, FILM COATED in 1 BOTTLE (65162-021-09) 2017-05-170000-00-00NoNoCurrent
65162-021-11651620021111000 TABLET, FILM COATED in 1 BOTTLE (65162-021-11) 2017-05-170000-00-00NoNoCurrent
65162-021-5065162002150500 TABLET, FILM COATED in 1 BOTTLE (65162-021-50) 2017-05-170000-00-00NoNoCurrent