Escitalopram oxalate

Product NDC
71610-534
11-digit product format
716100534
Labeler code
71610
Product ID
71610-534_2b8bb776-9f66-415a-b869-aded0e844450
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078604
Marketing category
ANDA
Marketing start
2012-10-01
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 oxalate
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
71610-534-60Escitalopram oxalate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-534ESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20210424_900b7a2f-23e7-4c78-bd6e-549bbe09883e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN900b7a2f-23e7-4c78-bd6e-549bbe09883e1
351250escitalopram 20 MG Oral TabletSCD900b7a2f-23e7-4c78-bd6e-549bbe09883e1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY900b7a2f-23e7-4c78-bd6e-549bbe09883e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-534-607161005346090 TABLET, FILM COATED in 1 BOTTLE (71610-534-60) 2021-03-090000-00-00NoNoCurrent