FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-6025
11-digit product format
500906025
Labeler code
50090
Product ID
50090-6025_34b7a8f8-d58a-4907-be28-c6f63057a872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
Marketing end
0000-00-00
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
2023-12-31
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
50090-6025-02024-01-30C16284748780-11030e365-6ff1-111a-e063-dadaa90a10e2These 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
50090-6025-0Escitalopram32 in 1 CARTONTABLET, FILM COATED322
50090-6025-0Escitalopram1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6025-0EA - Each50090-6025d219dc8b-3c23-4d57-a2c6-ac98a91aa1a512022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6025ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20220702_b2f51151-2cce-4036-8a5e-9fb6a9a6fcc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNb2f51151-2cce-4036-8a5e-9fb6a9a6fcc02
351250escitalopram 20 MG Oral TabletSCDb2f51151-2cce-4036-8a5e-9fb6a9a6fcc02
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYb2f51151-2cce-4036-8a5e-9fb6a9a6fcc02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6025-05009060250032 BLISTER PACK in 1 CARTON (50090-6025-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK32 blister pack2022-06-280000-00-00NoNoCurrent