FDA.reportPublic FDA data

escitalopram

Product NDC
70518-4239
11-digit product format
705184239
Labeler code
70518
Product ID
70518-4239_38f3e618-59de-4504-e063-6394a90afa55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2024-12-13
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
70518-4239-0escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4239-1escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
70518-4239-2escitalopram7 in 1 BOTTLE, PLASTICTABLET, FILM COATED74
70518-4239-3escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4239ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]2Current NDC, 4 package rows20250228_53a7e974-9945-4e42-8395-b567bf9f1c4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN53a7e974-9945-4e42-8395-b567bf9f1c4e4
351250escitalopram 20 MG Oral TabletSCD53a7e974-9945-4e42-8395-b567bf9f1c4e4
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY53a7e974-9945-4e42-8395-b567bf9f1c4e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4239-07051842390030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4239-0) 2024-12-13NoNoCurrent
70518-4239-17051842390190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4239-1) 2025-02-25NoNoCurrent
70518-4239-2705184239027 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4239-2) 2025-06-19NoNoCurrent
70518-4239-37051842390330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4239-3) 2025-07-01NoNoCurrent