ESCITALOPRAM OXALATE

Product NDC
43602-473
11-digit product format
436020473
Labeler code
43602
Product ID
43602-473_c891ea0b-ed9d-4e75-a529-2b8a651034d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET
Route
ORAL
Labeler
Ascent Pharmaceuticals, Inc
Application
ANDA215177
Marketing category
ANDA
Marketing start
2025-07-15
Substance
ESCITALOPRAM OXALATE
Active strength
5 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 OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249, 351250

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
43602-473-10ESCITALOPRAM OXALATE1000 in 1 BOTTLETABLET10001
43602-473-30ESCITALOPRAM OXALATE30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN1285841d-d9f8-49c6-9456-bf51c8e372711
351250escitalopram oxalate 20 MG Oral TabletPSN1285841d-d9f8-49c6-9456-bf51c8e372711
351249escitalopram oxalate 5 MG Oral TabletPSN1285841d-d9f8-49c6-9456-bf51c8e372711
349332escitalopram 10 MG Oral TabletSCD1285841d-d9f8-49c6-9456-bf51c8e372711
351250escitalopram 20 MG Oral TabletSCD1285841d-d9f8-49c6-9456-bf51c8e372711
351249escitalopram 5 MG Oral TabletSCD1285841d-d9f8-49c6-9456-bf51c8e372711
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY1285841d-d9f8-49c6-9456-bf51c8e372711
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY1285841d-d9f8-49c6-9456-bf51c8e372711
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY1285841d-d9f8-49c6-9456-bf51c8e372711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43602-473-10436020473101000 TABLET in 1 BOTTLE (43602-473-10) 1000 tablet2025-07-15NoNoHistorical
43602-473-304360204733030 TABLET in 1 BOTTLE (43602-473-30) 30 tablet2025-07-15NoNoHistorical