FDA.reportPublic FDA data

Escitalopram

Product NDC
71335-1241
11-digit product format
713351241
Labeler code
71335
Product ID
71335-1241_f7726916-4977-46dc-bb0d-4de18473548b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
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
Rxcui351249

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
71335-1241-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED30103
71335-1241-2Escitalopram60 in 1 BOTTLETABLET, FILM COATED60103
71335-1241-3Escitalopram90 in 1 BOTTLETABLET, FILM COATED90103
71335-1241-4Escitalopram100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1241ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20240407_20281fe6-7db9-4b33-8418-b25e6a5404ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN20281fe6-7db9-4b33-8418-b25e6a5404ca103
351249escitalopram 5 MG Oral TabletSCD20281fe6-7db9-4b33-8418-b25e6a5404ca103
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY20281fe6-7db9-4b33-8418-b25e6a5404ca103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1241-17133512410130 TABLET, FILM COATED in 1 BOTTLE (71335-1241-1) 2019-07-020000-00-00NoNoCurrent
71335-1241-27133512410260 TABLET, FILM COATED in 1 BOTTLE (71335-1241-2) 2024-04-030000-00-00NoNoCurrent
71335-1241-37133512410390 TABLET, FILM COATED in 1 BOTTLE (71335-1241-3) 2019-06-040000-00-00NoNoCurrent
71335-1241-471335124104100 TABLET, FILM COATED in 1 BOTTLE (71335-1241-4) 2024-04-03NoNoHistorical