FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
71205-792
11-digit product format
712050792
Labeler code
71205
Product ID
71205-792_8201a719-7837-45fb-b991-4fcdbf006d24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090939
Marketing category
ANDA
Marketing start
2012-09-11
Substance
ESCITALOPRAM OXALATE
Active strength
10 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 OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

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
71205-792-30escitalopram oxalate30 in 1 BOTTLETABLET301
71205-792-60escitalopram oxalate60 in 1 BOTTLETABLET601
71205-792-90escitalopram oxalate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-792-30EA - Each71205-7927fe7f893-4cfa-422b-b345-7fbf3360eca612023-08-08
71205-792-60EA - Each71205-7929374ccde-9745-4a50-9d6a-7a553c10a1ae12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-792ESCITALOPRAM OXALATE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20230422_8201a719-7837-45fb-b991-4fcdbf006d24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN8201a719-7837-45fb-b991-4fcdbf006d241
349332escitalopram 10 MG Oral TabletSCD8201a719-7837-45fb-b991-4fcdbf006d241
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY8201a719-7837-45fb-b991-4fcdbf006d241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-792-307120507923030 TABLET in 1 BOTTLE (71205-792-30) 30 tablet2023-04-18NoNoCurrent
71205-792-607120507926060 TABLET in 1 BOTTLE (71205-792-60) 60 tablet2023-04-18NoNoCurrent
71205-792-907120507929090 TABLET in 1 BOTTLE (71205-792-90) 90 tablet2023-04-18NoNoCurrent