FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-5704
11-digit product format
500905704
Labeler code
50090
Product ID
50090-5704_b2f50916-61d5-4759-8f01-ccbb414d6eba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitslopram
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078169
Marketing category
ANDA
Marketing start
2012-09-10
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
2022-12-31
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
50090-5704-02023-01-30C16284748780-1f386c649-e76e-0266-e053-dadaa90a7c1aThese 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
50090-5704-0Escitalopram90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5704-0EA - Each50090-57049cfb75d4-91a6-4958-b95f-1b006794913212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5704ESCITALOPRAM (ESCITSLOPRAM) TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20211028_25d450c1-932f-4f5e-b5f7-d3824d3c4efd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram 10 MG Oral TabletSCD25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY25d450c1-932f-4f5e-b5f7-d3824d3c4efd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5704-05009057040090 TABLET in 1 BOTTLE (50090-5704-0) 90 tablet2021-09-230000-00-00NoNoCurrent