escitalopram

Product NDC
67046-1472
11-digit product format
670461472
Labeler code
67046
Product ID
67046-1472_2d549d32-c4fa-349b-e063-6294a90a7904
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078777
Marketing category
ANDA
Marketing start
2025-02-04
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
67046-1472-3escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1472ESCITALOPRAM TABLET, FILM COATED [COUPLER LLC]1Current NDC, 1 package rows20250206_2d54a1cf-29cd-c485-e063-6394a90aeba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN2d54a1cf-29cd-c485-e063-6394a90aeba31
351249escitalopram 5 MG Oral TabletSCD2d54a1cf-29cd-c485-e063-6394a90aeba31
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2d54a1cf-29cd-c485-e063-6394a90aeba31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1472-36704614720330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1472-3) 2025-02-04NoNoHistorical