FDA.reportPublic FDA data

escitalopram

Product NDC
50090-7177
11-digit product format
500907177
Labeler code
50090
Product ID
50090-7177_bff6c207-0f4b-42da-8aa1-d8fdd0e55188
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
Substance
ESCITALOPRAM OXALATE
Active strength
5 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 OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

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
50090-7177-0escitalopram90 in 1 BOTTLETABLET, FILM COATED903
50090-7177-1escitalopram30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7177-0EA - Each50090-717745cc74c8-50d5-44ee-bda2-e81b7626c96d12024-07-12
50090-7177-1EA - Each50090-717759d22c50-f8cf-416d-aef4-f2d3f161a24312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7177ESCITALOPRAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20250406_3965ca55-a5ff-4ed0-940c-363d74683fab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN3965ca55-a5ff-4ed0-940c-363d74683fab3
351249escitalopram 5 MG Oral TabletSCD3965ca55-a5ff-4ed0-940c-363d74683fab3
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY3965ca55-a5ff-4ed0-940c-363d74683fab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7177-05009071770090 TABLET, FILM COATED in 1 BOTTLE (50090-7177-0) 2024-05-30NoNoCurrent
50090-7177-15009071770130 TABLET, FILM COATED in 1 BOTTLE (50090-7177-1) 2024-05-30NoNoCurrent