escitalopram

Product NDC
33342-053
11-digit product format
333420053
Labeler code
33342
Product ID
33342-053_6dea1a7d-7262-4d3e-9c9e-1db9c8587066
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
SOLUTION
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202754
Marketing category
ANDA
Marketing start
2016-03-31
Substance
ESCITALOPRAM OXALATE
Active strength
5 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-053-28escitalopram240 mL in 1 BOTTLESOLUTION24011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-053-28ML - Milliliter33342-05382595574-6622-445d-b074-c37de47bbd5012018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-053ESCITALOPRAM SOLUTION [MACLEODS PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 1 package rows20240525_4d5c3142-b850-49b9-9f5c-81fe15ea7bfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSN4d5c3142-b850-49b9-9f5c-81fe15ea7bfb11
351285escitalopram 1 MG/ML Oral SolutionSCD4d5c3142-b850-49b9-9f5c-81fe15ea7bfb11
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSY4d5c3142-b850-49b9-9f5c-81fe15ea7bfb11
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSY4d5c3142-b850-49b9-9f5c-81fe15ea7bfb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-053-2833342005328240 mL in 1 BOTTLE (33342-053-28) 240 ml2016-03-310000-00-00NoNoCurrent