Escitalopram

Product NDC
71335-9687
11-digit product format
713359687
Labeler code
71335
Product ID
71335-9687_fada57d1-668f-4890-9873-f48716441db1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
71335-9687-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED30104
71335-9687-2Escitalopram60 in 1 BOTTLETABLET, FILM COATED60104
71335-9687-3Escitalopram90 in 1 BOTTLETABLET, FILM COATED90104
71335-9687-4Escitalopram100 in 1 BOTTLETABLET, FILM COATED100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9687ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 4 package rows20241122_ee5963ad-3b53-48e5-b7a9-b13af5740ef1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNee5963ad-3b53-48e5-b7a9-b13af5740ef1104
351249escitalopram 5 MG Oral TabletSCDee5963ad-3b53-48e5-b7a9-b13af5740ef1104
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYee5963ad-3b53-48e5-b7a9-b13af5740ef1104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9687-17133596870130 TABLET, FILM COATED in 1 BOTTLE (71335-9687-1) 2023-06-22NoNoCurrent
71335-9687-27133596870260 TABLET, FILM COATED in 1 BOTTLE (71335-9687-2) 2023-04-04NoNoCurrent
71335-9687-37133596870390 TABLET, FILM COATED in 1 BOTTLE (71335-9687-3) 2023-07-10NoNoCurrent
71335-9687-471335968704100 TABLET, FILM COATED in 1 BOTTLE (71335-9687-4) 2024-11-01NoNoCurrent