FDA.reportPublic FDA data

escitalopram

Product NDC
55154-7288
11-digit product format
551547288
Labeler code
55154
Product ID
55154-7288_9f7145c1-6b28-4b3a-8b3c-a3a032864bc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090939
Marketing category
ANDA
Marketing start
2014-10-15
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
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 OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351250

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
55154-7288-0escitalopram1 in 1 BLISTER PACKTABLET, FILM COATED119
55154-7288-0escitalopram10 in 1 BAGTABLET, FILM COATED1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7288ESCITALOPRAM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]16Current NDC, Legacy NDC, 2 package rows20250507_cb3f9af4-5bb4-48a8-b972-ff92cff1ea01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
351250escitalopram oxalate 20 MG Oral TabletPSNcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
349332escitalopram 10 MG Oral TabletSCDcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
351250escitalopram 20 MG Oral TabletSCDcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7288-05515472880010 BLISTER PACK in 1 BAG (55154-7288-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2014-10-150000-00-00NoNoCurrent