Escitalopram oxalate

Product NDC
76282-250
11-digit product format
762820250
Labeler code
76282
Product ID
76282-250_787c121b-d227-4f2f-aa8d-e2dd69790fa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA078604
Marketing category
ANDA
Marketing start
2012-10-01
Substance
ESCITALOPRAM OXALATE
Active strength
10 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 OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249, 351250

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
76282-250-01Escitalopram oxalate100 in 1 BOTTLETABLET, FILM COATED10012
76282-250-05Escitalopram oxalate500 in 1 BOTTLETABLET, FILM COATED50012
76282-250-10Escitalopram oxalate1000 in 1 BOTTLETABLET, FILM COATED100012
76282-250-30Escitalopram oxalate30 in 1 BOTTLETABLET, FILM COATED3012
76282-250-90Escitalopram oxalate90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-250-10EA - Each76282-25018eaae42-6683-49d5-9c87-ffd955e7be3912014-01-04
76282-250-30EA - Each76282-25063e04e8f-6657-4ad8-8ad7-90cd135bf6b212014-01-04
76282-250-90EA - Each76282-2503fe15cc3-2ea2-43c0-ba35-f76f147651aa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-250ESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 5 package rows20240831_8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
351250escitalopram oxalate 20 MG Oral TabletPSN8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
351249escitalopram oxalate 5 MG Oral TabletPSN8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
349332escitalopram 10 MG Oral TabletSCD8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
351250escitalopram 20 MG Oral TabletSCD8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
351249escitalopram 5 MG Oral TabletSCD8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-250-0176282025001100 TABLET, FILM COATED in 1 BOTTLE (76282-250-01) 2012-10-010000-00-00NoNoCurrent
76282-250-0576282025005500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05) 2012-10-010000-00-00NoNoCurrent
76282-250-10762820250101000 TABLET, FILM COATED in 1 BOTTLE (76282-250-10) 2012-10-010000-00-00NoNoCurrent
76282-250-307628202503030 TABLET, FILM COATED in 1 BOTTLE (76282-250-30) 2012-10-010000-00-00NoNoCurrent
76282-250-907628202509090 TABLET, FILM COATED in 1 BOTTLE (76282-250-90) 2012-10-010000-00-00NoNoCurrent