Escitalopram

Product NDC
51672-1348
11-digit product format
516721348
Labeler code
51672
Product ID
51672-1348_38e51a59-5806-77a6-e063-6394a90af6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA079121
Marketing category
ANDA
Marketing start
2012-05-03
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1348-1Escitalopram240 mL in 1 BOTTLESOLUTION24013
51672-1348-1Escitalopram1 in 1 CARTONSOLUTION113
51672-1348-8Escitalopram1 in 1 CARTONSOLUTION113
51672-1348-8Escitalopram120 mL in 1 BOTTLESOLUTION12013
51672-1348-9Escitalopram480 mL in 1 BOTTLESOLUTION48013
51672-1348-9Escitalopram1 in 1 CARTONSOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1348-1ML - Milliliter51672-13488e4fe186-118e-408c-af78-78019744d31e12013-11-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1348ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]12Current NDC, Legacy NDC, 6 package rows20210703_c871d3fe-5ca2-410c-976d-9ec4b72c878f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSNc871d3fe-5ca2-410c-976d-9ec4b72c878f13
351285escitalopram 1 MG/ML Oral SolutionSCDc871d3fe-5ca2-410c-976d-9ec4b72c878f13
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSYc871d3fe-5ca2-410c-976d-9ec4b72c878f13
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSYc871d3fe-5ca2-410c-976d-9ec4b72c878f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1348-1516721348011 BOTTLE in 1 CARTON (51672-1348-1) / 240 mL in 1 BOTTLE1 bottle2012-05-030000-00-00NoNoCurrent
51672-1348-8516721348081 BOTTLE in 1 CARTON (51672-1348-8) / 120 mL in 1 BOTTLE1 bottle2012-05-030000-00-00NoNoCurrent
51672-1348-9516721348091 BOTTLE in 1 CARTON (51672-1348-9) / 480 mL in 1 BOTTLE1 bottle2012-05-030000-00-00NoNoCurrent