escitalopram

Product NDC
70518-4300
11-digit product format
705184300
Labeler code
70518
Product ID
70518-4300_38f2532b-84e2-7b40-e063-6394a90a4aa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2025-03-03
Substance
ESCITALOPRAM OXALATE
Active strength
5 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 OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

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
70518-4300-0escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED302
70518-4300-1escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4300ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 2 package rows20250305_d75e3b97-1ead-4e7b-9ae3-3626aede1efd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNd75e3b97-1ead-4e7b-9ae3-3626aede1efd2
351249escitalopram 5 MG Oral TabletSCDd75e3b97-1ead-4e7b-9ae3-3626aede1efd2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYd75e3b97-1ead-4e7b-9ae3-3626aede1efd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4300-07051843000030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4300-0) 2025-03-03NoNoCurrent
70518-4300-17051843000190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4300-1) 2025-07-01NoNoCurrent