FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-6534
11-digit product format
500906534
Labeler code
50090
Product ID
50090-6534_488baa4a-7e4b-47f3-94b2-8aa729de9cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
Substance
ESCITALOPRAM OXALATE
Active strength
20 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
Listing expiration
2026-12-31

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
50090-6534-0Escitalopram30 in 1 BOTTLETABLET, FILM COATED303
50090-6534-1Escitalopram90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6534-0EA - Each50090-6534fa0d1e4d-a375-400e-9f9d-75d2987fc56b12023-08-08
50090-6534-1EA - Each50090-653471e86aa5-383d-4554-b179-26cd19dc77b112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6534ESCITALOPRAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20240426_2ffc6ec3-830f-46bc-9b3f-7c42cefa39b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN2ffc6ec3-830f-46bc-9b3f-7c42cefa39b23
351250escitalopram 20 MG Oral TabletSCD2ffc6ec3-830f-46bc-9b3f-7c42cefa39b23
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2ffc6ec3-830f-46bc-9b3f-7c42cefa39b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6534-05009065340030 TABLET, FILM COATED in 1 BOTTLE (50090-6534-0) 2023-06-28NoNoHistorical
50090-6534-15009065340190 TABLET, FILM COATED in 1 BOTTLE (50090-6534-1) 2023-06-28NoNoHistorical