FDA.reportPublic FDA data

escitalopram

Product NDC
70518-3923
11-digit product format
705183923
Labeler code
70518
Product ID
70518-3923_3c542b5d-bc07-5312-e063-6294a90af65b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-11-22
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
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 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
70518-3923-0escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-3923-1escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908
70518-3923-2escitalopram60 in 1 BOTTLE, PLASTICTABLET, FILM COATED608
70518-3923-3escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
70518-3923-4escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3923ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, 5 package rows20250119_76a8aedd-7853-4d3f-9a00-f8222f55bea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN76a8aedd-7853-4d3f-9a00-f8222f55bea88
349332escitalopram 10 MG Oral TabletSCD76a8aedd-7853-4d3f-9a00-f8222f55bea88
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY76a8aedd-7853-4d3f-9a00-f8222f55bea88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3923-07051839230030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3923-0) 2023-11-22NoNoHistorical
70518-3923-17051839230190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3923-1) 2024-07-29NoNoHistorical
70518-3923-27051839230260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3923-2) 2024-12-04NoNoHistorical
70518-3923-37051839230330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3923-3) 2025-01-16NoNoHistorical
70518-3923-47051839230430 TABLET, FILM COATED in 1 BLISTER PACK (70518-3923-4) 2025-08-14NoNoHistorical