FDA.reportPublic FDA data

Escitalopram

Product NDC
50436-0054
11-digit product format
504360054
Labeler code
50436
Product ID
50436-0054_ff3894ec-fd44-4499-b70a-3a696b7b7201
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078777
Marketing category
ANDA
Marketing start
2012-09-11
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0054-12020-01-31C16284748780-19d75b9d1-1ddc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0054-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0054-1EA - Each50436-00546f1b92ff-5cec-49ea-a8db-00bd7f26e3aa12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Escitalopram OxalateACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0054ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [UNIT DOSE SERVICES]7Legacy NDC, 1 package rows20171108_f0626986-7a43-4cf6-bde2-29318b78e6c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNf0626986-7a43-4cf6-bde2-29318b78e6c87
351250escitalopram 20 MG Oral TabletSCDf0626986-7a43-4cf6-bde2-29318b78e6c87
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf0626986-7a43-4cf6-bde2-29318b78e6c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0054-15043600540130 in 1 BOTTLEHistorical