FDA.reportPublic FDA data

Escitalopram

Product NDC
72789-194
11-digit product format
727890194
Labeler code
72789
Product ID
72789-194_4b0835eb-6098-311e-e063-6394a90a3fae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-19
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
72789-194-30Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
72789-194-90Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-194-30EA - Each72789-1940d4128d3-2d06-4165-99bf-3329a33f567c12021-07-15
72789-194-90EA - Each72789-1941f16c2ea-6313-4ce0-88d9-0f2fc45d5f3512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-194ESCITALOPRAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20250403_83510549-bd47-4969-aba0-c149a0fbb7f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN83510549-bd47-4969-aba0-c149a0fbb7f317
349332escitalopram 10 MG Oral TabletSCD83510549-bd47-4969-aba0-c149a0fbb7f317
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY83510549-bd47-4969-aba0-c149a0fbb7f317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-194-307278901943030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-194-30) 2021-06-220000-00-00NoNoCurrent
72789-194-907278901949090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-194-90) 2021-06-140000-00-00NoNoCurrent