FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-6496
11-digit product format
500906496
Labeler code
50090
Product ID
50090-6496_3e7b0da2-d2e3-491d-9c2a-f1b0ad7554af
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
10 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 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
50090-6496-0Escitalopram30 in 1 BOTTLETABLET, FILM COATED305
50090-6496-1Escitalopram90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6496-0EA - Each50090-6496dfcc7d63-edd3-4f37-bb26-91fcb3194eba12023-07-06
50090-6496-1EA - Each50090-649627507085-bc01-4bcf-9987-c292b750a96812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6496ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20240501_b85ef018-0217-4ddf-885d-206acc0a5f84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNb85ef018-0217-4ddf-885d-206acc0a5f845
349332escitalopram 10 MG Oral TabletSCDb85ef018-0217-4ddf-885d-206acc0a5f845
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb85ef018-0217-4ddf-885d-206acc0a5f845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6496-05009064960030 TABLET, FILM COATED in 1 BOTTLE (50090-6496-0) 2023-05-24NoNoCurrent
50090-6496-15009064960190 TABLET, FILM COATED in 1 BOTTLE (50090-6496-1) 2023-05-26NoNoCurrent