Escitalopram

Product NDC
80425-0320
11-digit product format
804250320
Labeler code
80425
Product ID
80425-0320_2a9bf7d3-46db-0dfa-e063-6394a90a76a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078032
Marketing category
ANDA
Marketing start
2023-04-11
Substance
ESCITALOPRAM OXALATE
Active strength
10 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
80425-0320-18042503200130 TABLET, FILM COATED in 1 BOTTLE (80425-0320-1) 2023-04-11NoNoHistorical
80425-0320-28042503200260 TABLET, FILM COATED in 1 BOTTLE (80425-0320-2) 2023-04-11NoNoHistorical
80425-0320-38042503200360 TABLET, FILM COATED in 1 BOTTLE (80425-0320-3) 2023-04-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Escitalopram TabletsAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL2