Escitalopram

Product NDC
68084-617
11-digit product format
680840617
Labeler code
68084
Product ID
68084-617_30deba4d-85ab-64e3-e063-6394a90a085e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-10-08
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 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
68084-617-01Escitalopram100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10012
68084-617-11Escitalopram1 in 1 BLISTER PACKTABLET, FILM COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-617-01EA - Each68084-61755954bca-b300-43eb-8f0c-189dc1ce0d6e12013-02-13
68084-617-11EA - Each68084-617b1ba285c-c612-48f2-a408-967ae71a684a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-617ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20250323_3019a647-9bcf-48cf-928c-0467f9b921a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN3019a647-9bcf-48cf-928c-0467f9b921a812
351250escitalopram oxalate 20 MG Oral TabletPSN3019a647-9bcf-48cf-928c-0467f9b921a812
349332escitalopram 10 MG Oral TabletSCD3019a647-9bcf-48cf-928c-0467f9b921a812
351250escitalopram 20 MG Oral TabletSCD3019a647-9bcf-48cf-928c-0467f9b921a812
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY3019a647-9bcf-48cf-928c-0467f9b921a812
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY3019a647-9bcf-48cf-928c-0467f9b921a812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-617-0168084061701100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-617-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-617-11) 100 blister pack2012-10-080000-00-00NoNoCurrent
68084-617-11680840617111 in 1 BLISTER PACKHistorical