Escitalopram Oxalate

Product NDC
72603-149
11-digit product format
726030149
Labeler code
72603
Product ID
72603-149_cb888b2f-8092-43a1-8542-a10e2b004369
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202210
Marketing category
ANDA
Marketing start
2024-01-08
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
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-149-01Escitalopram Oxalate1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-149ESCITALOPRAM OXALATE TABLET, FILM COATED [NORTHSTAR RXLLC]2Current NDC, 1 package rows20240706_81840aec-96fd-4af2-bd10-3f38d068f39a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN81840aec-96fd-4af2-bd10-3f38d068f39a2
351250escitalopram oxalate 20 MG Oral TabletPSN81840aec-96fd-4af2-bd10-3f38d068f39a2
351249escitalopram oxalate 5 MG Oral TabletPSN81840aec-96fd-4af2-bd10-3f38d068f39a2
349332escitalopram 10 MG Oral TabletSCD81840aec-96fd-4af2-bd10-3f38d068f39a2
351250escitalopram 20 MG Oral TabletSCD81840aec-96fd-4af2-bd10-3f38d068f39a2
351249escitalopram 5 MG Oral TabletSCD81840aec-96fd-4af2-bd10-3f38d068f39a2
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY81840aec-96fd-4af2-bd10-3f38d068f39a2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY81840aec-96fd-4af2-bd10-3f38d068f39a2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY81840aec-96fd-4af2-bd10-3f38d068f39a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-149-01726030149011000 TABLET, FILM COATED in 1 BOTTLE (72603-149-01) 2024-01-08NoNoCurrent