FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-6023
11-digit product format
500906023
Labeler code
50090
Product ID
50090-6023_77d085a4-81b9-4807-8b43-3b10780c2e77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6023-0Escitalopram30 in 1 BOTTLETABLET, FILM COATED301
50090-6023-1Escitalopram90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6023-0EA - Each50090-602374825f8a-5a37-4033-a52f-30330aa9c91112023-05-05
50090-6023-1EA - Each50090-6023c9afa8bd-33bf-4104-949f-fce06b9ba41912023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6023ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230418_10b25a10-c5e7-479b-a9f5-7eeafd802323.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN10b25a10-c5e7-479b-a9f5-7eeafd8023231
351250escitalopram 20 MG Oral TabletSCD10b25a10-c5e7-479b-a9f5-7eeafd8023231
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY10b25a10-c5e7-479b-a9f5-7eeafd8023231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6023-05009060230030 TABLET, FILM COATED in 1 BOTTLE (50090-6023-0) 2022-06-27NoNoCurrent
50090-6023-15009060230190 TABLET, FILM COATED in 1 BOTTLE (50090-6023-1) 2022-06-27NoNoCurrent