FDA.reportPublic FDA data

Escitalopram

Product NDC
54458-891
11-digit product format
544580891
Labeler code
54458
Product ID
54458-891_8acaf253-c8f8-466a-9155-eb3660af08b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076765
Marketing category
ANDA
Marketing start
2013-09-20
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54458-891-102021-01-29C16284748780-1ba0f9c33-3f2a-a910-e053-dadaa90a0b85These 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
54458-891-162021-01-29C16284748780-1ba0f9c33-3f2a-a910-e053-dadaa90a0b85These 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
54458-891-10Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED3018
54458-891-16Escitalopram30 in 1 BOTTLETABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-891-10EA - Each54458-8919ea9295c-c5eb-4314-af0c-af97046f592e12013-12-02
54458-891-16EA - Each54458-891ba3fdb21-507f-4bce-84da-9b3fe0ced95a12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
MANNITOLINACTIVE INGREDIENT3OWL53L36AESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-891ESCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]18Legacy NDC, 2 package rows20191219_3bcd1a0c-a411-4318-bdd9-17b91c082ca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN3bcd1a0c-a411-4318-bdd9-17b91c082ca118
351250escitalopram oxalate 20 MG Oral TabletPSN3bcd1a0c-a411-4318-bdd9-17b91c082ca118
349332escitalopram 10 MG Oral TabletSCD3bcd1a0c-a411-4318-bdd9-17b91c082ca118
351250escitalopram 20 MG Oral TabletSCD3bcd1a0c-a411-4318-bdd9-17b91c082ca118
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY3bcd1a0c-a411-4318-bdd9-17b91c082ca118
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY3bcd1a0c-a411-4318-bdd9-17b91c082ca118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-891-105445808911030 in 1 BLISTER PACKHistorical
54458-891-165445808911630 in 1 BOTTLEHistorical