Escitalopram Oxalate

Product NDC
65162-705
11-digit product format
651620705
Labeler code
65162
Product ID
65162-705_d29f980a-e696-4020-8bf9-8f81016c0699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA202227
Marketing category
ANDA
Marketing start
2011-09-03
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 Oxalate
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-705-88Escitalopram Oxalate240 mL in 1 BOTTLESOLUTION24038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-705-88ML - Milliliter65162-7051477ca66-17c5-4cc0-9c87-4a1baaf68e5c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
SORBITOLINACTIVE INGREDIENT506T60A25RESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
WATERINACTIVE INGREDIENT059QF0KO0RESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-705ESCITALOPRAM OXALATE (ESCITALOPRAM) SOLUTION [AMNEAL PHARMACEUTICALS LLC]38Current NDC, Legacy NDC, 1 package rows20250502_09894a38-4e3a-475d-96cd-c6c8ed87869a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSN09894a38-4e3a-475d-96cd-c6c8ed87869a38
351285escitalopram 1 MG/ML Oral SolutionSCD09894a38-4e3a-475d-96cd-c6c8ed87869a38
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSY09894a38-4e3a-475d-96cd-c6c8ed87869a38
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSY09894a38-4e3a-475d-96cd-c6c8ed87869a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-705-8865162070588240 mL in 1 BOTTLE (65162-705-88) 240 ml2011-09-030000-00-00NoNoCurrent