FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
71335-0685
11-digit product format
713350685
Labeler code
71335
Product ID
71335-0685_7cb6e260-dd56-42fd-aaca-4cc1fd460884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090939
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 oxalate
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
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0685-1escitalopram oxalate60 in 1 BOTTLETABLET60106
71335-0685-2escitalopram oxalate28 in 1 BOTTLETABLET28106
71335-0685-3escitalopram oxalate30 in 1 BOTTLETABLET30106
71335-0685-4escitalopram oxalate90 in 1 BOTTLETABLET90106
71335-0685-5escitalopram oxalate120 in 1 BOTTLETABLET120106
71335-0685-6escitalopram oxalate100 in 1 BOTTLETABLET100106
71335-0685-7escitalopram oxalate45 in 1 BOTTLETABLET45106
71335-0685-8escitalopram oxalate180 in 1 BOTTLETABLET180106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0685-1EA - Each71335-06857213bb1c-ee42-4c47-9a38-6524b16a5ca812018-09-05
71335-0685-3EA - Each71335-068563a9d40d-9e68-47e6-acd0-badaecd4552b12018-09-05
71335-0685-4EA - Each71335-0685df33ae5b-8e69-4f23-8ebe-8a52fd7ece3412018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0685ESCITALOPRAM OXALATE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 8 package rows20241113_86cfcd96-6397-42ef-8a79-f62706f0aca6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN86cfcd96-6397-42ef-8a79-f62706f0aca6106
351250escitalopram 20 MG Oral TabletSCD86cfcd96-6397-42ef-8a79-f62706f0aca6106
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY86cfcd96-6397-42ef-8a79-f62706f0aca6106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0685-17133506850160 TABLET in 1 BOTTLE (71335-0685-1) 60 tablet2018-02-270000-00-00NoNoCurrent
71335-0685-27133506850228 TABLET in 1 BOTTLE (71335-0685-2) 28 tablet2024-10-300000-00-00NoNoCurrent
71335-0685-37133506850330 TABLET in 1 BOTTLE (71335-0685-3) 30 tablet2018-02-220000-00-00NoNoCurrent
71335-0685-47133506850490 TABLET in 1 BOTTLE (71335-0685-4) 90 tablet2018-02-120000-00-00NoNoCurrent
71335-0685-571335068505120 TABLET in 1 BOTTLE (71335-0685-5) 120 tablet2024-10-300000-00-00NoNoCurrent
71335-0685-671335068506100 TABLET in 1 BOTTLE (71335-0685-6) 100 tablet2024-10-300000-00-00NoNoCurrent
71335-0685-77133506850745 TABLET in 1 BOTTLE (71335-0685-7) 45 tablet2024-10-300000-00-00NoNoCurrent
71335-0685-871335068508180 TABLET in 1 BOTTLE (71335-0685-8) 180 tablet2024-10-300000-00-00NoNoCurrent