FDA.reportPublic FDA data

Escitalopram

Product NDC
68071-4985
11-digit product format
680714985
Labeler code
68071
Product ID
68071-4985_1b2eab54-08e3-1354-e063-6394a90a2faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-21
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
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 OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351250

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
68071-4985-32024-06-18C16284748780-1ba0f9c33-1d5d-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
68071-4985-32023-01-30C16284748780-1ba0f9c33-1d5d-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
68071-4985-32021-02-19C16284748780-1ba0f9c33-1d5d-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
68071-4985-32021-01-29C16284748780-1ba0f9c33-1d5d-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
68071-4985-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4985ESCITALOPRAM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240619_8e88bc86-d5e2-50ca-e053-2995a90a0f0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN8e88bc86-d5e2-50ca-e053-2995a90a0f0e3
351250escitalopram 20 MG Oral TabletSCD8e88bc86-d5e2-50ca-e053-2995a90a0f0e3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY8e88bc86-d5e2-50ca-e053-2995a90a0f0e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4985-36807149850330 TABLET, FILM COATED in 1 BOTTLE (68071-4985-3) 2019-07-250000-00-00NoNoCurrent