FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
72162-2240
11-digit product format
721622240
Labeler code
72162
Product ID
72162-2240_6d69ecb8-d0af-4247-a859-1e49e5dfc757
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 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
72162-2240-0escitalopram1000 in 1 BOTTLETABLET, FILM COATED1000105
72162-2240-1escitalopram100 in 1 BOTTLETABLET, FILM COATED100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2240-0EA - Each72162-22406ae3bfb9-b4a0-4709-ba86-19f024fa06ad12024-08-12
72162-2240-1EA - Each72162-22409079d1cb-401b-4857-946a-b999fda2e72a12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2240ESCITALOPRAM OXALATE TABLET [BRYANT RANCH PREPACK]104Current NDC, 2 package rows20241123_cb30d1c5-2280-465f-84f4-4367ad5f1a31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNcb30d1c5-2280-465f-84f4-4367ad5f1a31105
351250escitalopram 20 MG Oral TabletSCDcb30d1c5-2280-465f-84f4-4367ad5f1a31105
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYcb30d1c5-2280-465f-84f4-4367ad5f1a31105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2240-0721622240001000 TABLET, FILM COATED in 1 BOTTLE (72162-2240-0) 2012-09-11NoNoCurrent
72162-2240-172162224001100 TABLET, FILM COATED in 1 BOTTLE (72162-2240-1) 2012-09-11NoNoCurrent