FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
72162-2241
11-digit product format
721622241
Labeler code
72162
Product ID
72162-2241_3bb03754-0437-4f83-8ad5-0970d9788c01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET, FILM COATED
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 OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2241-0escitalopram1000 in 1 BOTTLETABLET, FILM COATED1000105
72162-2241-1escitalopram100 in 1 BOTTLETABLET, FILM COATED100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2241-0EA - Each72162-2241aa904c5d-5632-424f-af40-304f9ca37ac212024-02-14
72162-2241-1EA - Each72162-224173b24fa1-e00e-47c7-b639-30132ba70a9012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2241ESCITALOPRAM OXALATE TABLET [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20241123_0de88dad-d54c-4773-a5d6-a705e012973a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN0de88dad-d54c-4773-a5d6-a705e012973a105
349332escitalopram 10 MG Oral TabletSCD0de88dad-d54c-4773-a5d6-a705e012973a105
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY0de88dad-d54c-4773-a5d6-a705e012973a105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2241-0721622241001000 TABLET, FILM COATED in 1 BOTTLE (72162-2241-0) 2012-09-11NoNoCurrent
72162-2241-172162224101100 TABLET, FILM COATED in 1 BOTTLE (72162-2241-1) 2012-09-11NoNoCurrent