FDA.reportPublic FDA data

Escitalopram

Product NDC
33261-954
11-digit product format
332610954
Labeler code
33261
Product ID
33261-954_3c613066-4694-4de8-859a-7061e2a2e7b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076765
Marketing category
ANDA
Marketing start
2012-03-14
Marketing end
0000-00-00
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
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
33261-954-302020-01-31C16284748780-19d75b9d0-822d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002
33261-954-552020-01-31C16284748780-19d75b9d0-822d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002
33261-954-602020-01-31C16284748780-19d75b9d0-822d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002
33261-954-902020-01-31C16284748780-19d75b9d0-822d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-954-30Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
33261-954-55Escitalopram500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002
33261-954-60Escitalopram60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
33261-954-90Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-954-30EA - Each33261-9548ff8b29d-9f01-46dd-be3f-c1a06f50ef2f12015-10-02
33261-954-55EA - Each33261-9541683372b-0ff7-40c1-a79e-5d72985ef0eb12018-11-06
33261-954-60EA - Each33261-954afda08e1-395c-4007-8139-3ed3865059f112017-03-06
33261-954-90EA - Each33261-95491d9bbe0-8c47-478b-916c-6d328bc9818512017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-954ESCITALOPRAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 4 package rows20170223_ca5e4559-736b-478e-a9e2-be4d9ff8a148.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNca5e4559-736b-478e-a9e2-be4d9ff8a1482
349332escitalopram 10 MG Oral TabletSCDca5e4559-736b-478e-a9e2-be4d9ff8a1482
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYca5e4559-736b-478e-a9e2-be4d9ff8a1482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-954-303326109543030 in 1 BOTTLE, PLASTICHistorical
33261-954-5533261095455500 in 1 BOTTLE, PLASTICHistorical
33261-954-603326109546060 in 1 BOTTLE, PLASTICHistorical
33261-954-903326109549090 in 1 BOTTLE, PLASTICHistorical