FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-6190
11-digit product format
500906190
Labeler code
50090
Product ID
50090-6190_639f9151-0f94-4585-9132-7ad5efe5a2b0
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
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

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
50090-6190-0Escitalopram30 in 1 BOTTLETABLET, FILM COATED307
50090-6190-1Escitalopram90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6190-0EA - Each50090-61907d0983e8-4dd0-4efa-b3b5-529770bbbf3412022-12-07
50090-6190-1EA - Each50090-61906142d5cf-7ffe-4bd2-acba-38483373a9a512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6190ESCITALOPRAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240426_a0344290-6e12-46c4-a11c-5347a770adbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNa0344290-6e12-46c4-a11c-5347a770adbe7
349332escitalopram 10 MG Oral TabletSCDa0344290-6e12-46c4-a11c-5347a770adbe7
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYa0344290-6e12-46c4-a11c-5347a770adbe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6190-05009061900030 TABLET, FILM COATED in 1 BOTTLE (50090-6190-0) 2022-10-280000-00-00NoNoCurrent
50090-6190-15009061900190 TABLET, FILM COATED in 1 BOTTLE (50090-6190-1) 2022-10-280000-00-00NoNoCurrent