FDA.reportPublic FDA data

Escitalopram

Product NDC
51655-284
11-digit product format
516550284
Labeler code
51655
Product ID
51655-284_48e710d5-cd0b-b488-e063-6394a90a8b6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078032
Marketing category
ANDA
Marketing start
2020-05-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

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
51655-284-262023-04-17C16284748780-1f386c64a-06b9-0266-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
51655-284-262023-01-30C16284748780-1f386c64a-06b9-0266-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
51655-284-26Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
51655-284-52Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-284-26EA - Each51655-2849fc160ba-4d15-422b-ab47-e1b2e545244312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-284ESCITALOPRAM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20241218_addccf96-cc60-6045-e053-2a95a90aaac0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNaddccf96-cc60-6045-e053-2a95a90aaac06
351250escitalopram 20 MG Oral TabletSCDaddccf96-cc60-6045-e053-2a95a90aaac06
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYaddccf96-cc60-6045-e053-2a95a90aaac06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-284-265165502842690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-284-26) 2020-05-130000-00-00NoNoCurrent
51655-284-525165502845230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-284-52) 2022-07-20NoNoHistorical