FDA.reportPublic FDA data

Escitalopram

Product NDC
72189-451
11-digit product format
721890451
Labeler code
72189
Product ID
72189-451_46164771-c4bd-9879-e063-6294a90ad050
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078032
Marketing category
ANDA
Marketing start
2023-03-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351250

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
72189-451-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED303
72189-451-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED603
72189-451-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-451ESCITALOPRAM TABLET, FILM COATED [DIRECT_RX]2Current NDC, 3 package rows20250123_f81e3858-f01e-1df6-e053-6394a90aef4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNf81e3858-f01e-1df6-e053-6394a90aef4f3
351250escitalopram 20 MG Oral TabletSCDf81e3858-f01e-1df6-e053-6394a90aef4f3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf81e3858-f01e-1df6-e053-6394a90aef4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-451-307218904513030 TABLET, FILM COATED in 1 BOTTLE (72189-451-30) 2023-03-30NoNoCurrent
72189-451-607218904516060 TABLET, FILM COATED in 1 BOTTLE (72189-451-60) 2023-03-30NoNoCurrent
72189-451-907218904519090 TABLET, FILM COATED in 1 BOTTLE (72189-451-90) 2023-03-30NoNoCurrent