Escitalopram

Product NDC
0615-8477
11-digit product format
006158477
Labeler code
0615
Product ID
0615-8477_356b8a10-241f-41e7-96fe-57590f373800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351250

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
0615-8477-05Escitalopram15 in 1 BLISTER PACKTABLET, FILM COATED151
0615-8477-39Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8477ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, 2 package rows20230721_ac9ede0c-7912-4e7d-83b3-964feee61215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNac9ede0c-7912-4e7d-83b3-964feee612151
351250escitalopram 20 MG Oral TabletSCDac9ede0c-7912-4e7d-83b3-964feee612151
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYac9ede0c-7912-4e7d-83b3-964feee612151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8477-050061584770515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8477-05) 2023-07-18NoNoCurrent
0615-8477-390061584773930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8477-39) 2023-07-18NoNoCurrent