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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5U85DBW7LOESCITALOPRAM OXALATE219861-08-2ESCITALOPRAM OXALATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8475-050061584750515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-05) 2023-08-10NoNoHistorical
0615-8475-390061584753930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-39) 2023-05-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EscitalopramNCS HealthCare of KY, LLC dba Vangard Labs2025-01-24HUMAN PRESCRIPTION DRUG LABEL4