Escitalopram

Product NDC
71610-425
11-digit product format
716100425
Labeler code
71610
Product ID
71610-425_09b866f0-4435-4d1a-9cc7-c6a5ea487cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-21
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5U85DBW7LOESCITALOPRAM OXALATE219861-08-2ESCITALOPRAM OXALATE
4O4S742ANYESCITALOPRAM128196-01-0Escitalopram

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-425-607161004256090 TABLET, FILM COATED in 1 BOTTLE (71610-425-60) 2020-05-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EscitalopramAphena Pharma Solutions - Tennessee, LLC2020-05-20HUMAN PRESCRIPTION DRUG LABEL1