FDA.reportPublic FDA data

Escitalopram Oxalate

Product NDC
50090-7200
11-digit product format
500907200
Labeler code
50090
Product ID
50090-7200_c54a04b2-8d7d-4a25-8f53-aa075eea042b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202210
Marketing category
ANDA
Marketing start
2024-01-08
Substance
ESCITALOPRAM OXALATE
Active strength
20 mg/21
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 OXALATE20 mg/21

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
50090-7200-0Escitalopram Oxalate30 in 1 BOTTLETABLET, FILM COATED301
50090-7200-1Escitalopram Oxalate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7200-0EA - Each50090-7200b23b970a-6df8-44fa-be06-3d1628a74eed12024-09-09
50090-7200-1EA - Each50090-7200e013c501-11ad-4042-bcd0-eaee346586f812024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7200ESCITALOPRAM OXALATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240802_c980262b-31f0-46df-902d-e593e1557fef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNc980262b-31f0-46df-902d-e593e1557fef1
351250escitalopram 20 MG Oral TabletSCDc980262b-31f0-46df-902d-e593e1557fef1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYc980262b-31f0-46df-902d-e593e1557fef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7200-05009072000030 TABLET, FILM COATED in 1 BOTTLE (50090-7200-0) 2024-07-30NoNoCurrent
50090-7200-15009072000190 TABLET, FILM COATED in 1 BOTTLE (50090-7200-1) 2024-07-30NoNoCurrent