FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
72162-2242
11-digit product format
721622242
Labeler code
72162
Product ID
72162-2242_a3f1acbc-6b69-4ce6-95a7-e51a2023ea50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090939
Marketing category
ANDA
Marketing start
2012-09-11
Substance
ESCITALOPRAM OXALATE
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
2027-12-31

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
72162-2242-0escitalopram1000 in 1 BOTTLETABLET, FILM COATED1000105
72162-2242-1escitalopram100 in 1 BOTTLETABLET, FILM COATED100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2242-0EA - Each72162-2242c2a6f70d-1f02-4782-9c77-bfb9c603580312024-08-12
72162-2242-1EA - Each72162-2242237667cd-6284-4700-9b98-a77a4138da6312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2242ESCITALOPRAM OXALATE TABLET [BRYANT RANCH PREPACK]104Current NDC, 2 package rows20241123_a0ff752d-cb30-4131-a7d6-cd66d8a47b1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNa0ff752d-cb30-4131-a7d6-cd66d8a47b1a105
351249escitalopram 5 MG Oral TabletSCDa0ff752d-cb30-4131-a7d6-cd66d8a47b1a105
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYa0ff752d-cb30-4131-a7d6-cd66d8a47b1a105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2242-0721622242001000 TABLET, FILM COATED in 1 BOTTLE (72162-2242-0) 2012-09-11NoNoCurrent
72162-2242-172162224201100 TABLET, FILM COATED in 1 BOTTLE (72162-2242-1) 2012-09-11NoNoCurrent