Escitalopram

Product NDC
76420-723
11-digit product format
764200723
Labeler code
76420
Product ID
76420-723_4ac15baa-6fcc-476b-e063-6294a90a2a89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

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
76420-723-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED1002
76420-723-05Escitalopram500 in 1 BOTTLETABLET, FILM COATED5002
76420-723-10Escitalopram10 in 1 BOTTLETABLET, FILM COATED102
76420-723-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED302
76420-723-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED602
76420-723-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-723ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, 6 package rows20240511_2957a003-7714-4e16-aeca-623fd6c5d702.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram oxalate 20 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram oxalate 5 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram 10 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram 20 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram 5 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-723-0176420072301100 TABLET, FILM COATED in 1 BOTTLE (76420-723-01) 2024-05-06NoNoHistorical
76420-723-0576420072305500 TABLET, FILM COATED in 1 BOTTLE (76420-723-05) 2024-05-06NoNoHistorical
76420-723-107642007231010 TABLET, FILM COATED in 1 BOTTLE (76420-723-10) 2024-05-06NoNoHistorical
76420-723-307642007233030 TABLET, FILM COATED in 1 BOTTLE (76420-723-30) 2024-05-06NoNoHistorical
76420-723-607642007236060 TABLET, FILM COATED in 1 BOTTLE (76420-723-60) 2024-05-06NoNoHistorical
76420-723-907642007239090 TABLET, FILM COATED in 1 BOTTLE (76420-723-90) 2024-05-06NoNoHistorical