FDA.reportPublic FDA data

Escitalopram

Product NDC
72789-311
11-digit product format
727890311
Labeler code
72789
Product ID
72789-311_31f54f70-b635-cb9e-e063-6394a90a329f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
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
72789-311-30Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
72789-311-90Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-311-30EA - Each72789-311cc3946c0-5e66-44e9-a931-db097ba9d7bb12023-09-05
72789-311-90EA - Each72789-311444b26a5-4df3-4d11-b820-53f59eb4b1bc12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-311ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, 2 package rows20250406_517a551a-6f60-4b8d-9341-63a41baff12d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN517a551a-6f60-4b8d-9341-63a41baff12d21
351250escitalopram 20 MG Oral TabletSCD517a551a-6f60-4b8d-9341-63a41baff12d21
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY517a551a-6f60-4b8d-9341-63a41baff12d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-311-307278903113030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-311-30) 2023-07-11NoNoCurrent
72789-311-907278903119090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-311-90) 2023-03-16NoNoCurrent