Escitalopram

Product NDC
0615-8475
11-digit product format
006158475
Labeler code
0615
Product ID
0615-8475_efdc3d31-555b-443b-bdc7-4729675ab6c1
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
5 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 OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249

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
0615-8475-05Escitalopram15 in 1 BLISTER PACKTABLET, FILM COATED154
0615-8475-39Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8475ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]4Current NDC, 2 package rows20250126_b29ae169-d60b-464a-9763-f1d8d9e0598d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram oxalate 5 MG Oral TabletPSNb29ae169-d60b-464a-9763-f1d8d9e0598d4
349332escitalopram 10 MG Oral TabletSCDb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram 5 MG Oral TabletSCDb29ae169-d60b-464a-9763-f1d8d9e0598d4
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYb29ae169-d60b-464a-9763-f1d8d9e0598d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8475-050061584750515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-05) 2023-08-10NoNoCurrent
0615-8475-390061584753930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-39) 2023-05-17NoNoCurrent