FDA.reportPublic FDA data

Escitalopram

Product NDC
67046-0355
11-digit product format
670460355
Labeler code
67046
Product ID
67046-0355_50888091-65b9-c7e2-e063-6394a90afe55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078032
Marketing category
ANDA
Marketing start
2026-04-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

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
67046-0355-3Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN5088d6cd-ec13-384d-e063-6394a90aee051
349332escitalopram 10 MG Oral TabletSCD5088d6cd-ec13-384d-e063-6394a90aee051
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY5088d6cd-ec13-384d-e063-6394a90aee051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-0355-36704603550330 TABLET, FILM COATED in 1 BLISTER PACK (67046-0355-3) 2026-04-28NoNoHistorical