FDA.reportPublic FDA data

Escitalopram

Product NDC
68071-3069
11-digit product format
680713069
Labeler code
68071
Product ID
68071-3069_1d8e7443-eb23-ccda-e063-6394a90ae343
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
68071-3069-32024-07-18C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-82024-07-18C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-32023-01-30C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-82023-01-30C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-32021-02-11C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-82021-02-11C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-32021-01-29C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002
68071-3069-82021-01-29C16284748780-1ba0f9c33-1c37-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram oxalate. ESCITALOPRAM Tablets USP for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3069-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED305
68071-3069-8Escitalopram28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3069ESCITALOPRAM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240720_4a645652-ae1f-3811-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN4a645652-ae1f-3811-e054-00144ff8d46c5
351250escitalopram 20 MG Oral TabletSCD4a645652-ae1f-3811-e054-00144ff8d46c5
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY4a645652-ae1f-3811-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3069-36807130690330 TABLET, FILM COATED in 1 BOTTLE (68071-3069-3) 2017-03-100000-00-00NoNoCurrent
68071-3069-86807130690828 TABLET, FILM COATED in 1 BOTTLE (68071-3069-8) 2017-03-100000-00-00NoNoCurrent