FDA.reportPublic FDA data

Lexapro

Product NDC
33261-699
11-digit product format
332610699
Labeler code
33261
Product ID
33261-699_d73d3c7c-5e0c-43b7-992c-105eb90c7103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESCITALOPRAM OXALATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA021323
Marketing category
NDA
Marketing start
2002-08-14
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-699-302020-01-31C16284748780-19d75b9d0-1dc8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lexapro® safely and effectively. See full prescribing information for Lexapro® Lexapro® (escitalopram oxalate) Tablets Lexapro® (escitalopram oxalate) Oral Solution Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-699-30Lexapro30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-699-30EA - Each33261-69925a00888-9a82-4871-be0e-bdccecfd22ed12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOLEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYLEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-699LEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140110_16c67e3e-9928-4ad8-b850-84ec4d333e9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
351250escitalopram oxalate 20 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272Lexapro 10 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273Lexapro 20 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272escitalopram 10 MG Oral Tablet [Lexapro]SBD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273escitalopram 20 MG Oral Tablet [Lexapro]SBD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
349332escitalopram 10 MG Oral TabletSCD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
351250escitalopram 20 MG Oral TabletSCD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272Lexapro (as escitalopram oxalate) 10 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273Lexapro (as escitalopram oxalate) 20 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272Lexapro 10 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273Lexapro 20 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-699-303326106993030 in 1 BOTTLE, PLASTICHistorical