Escitalopram

Product NDC
51655-116
11-digit product format
516550116
Labeler code
51655
Product ID
51655-116_48c3d134-d4dc-a5fc-e063-6294a90acd5a
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
2022-07-11
Substance
ESCITALOPRAM OXALATE
Active strength
5 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 OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-116-26Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
51655-116-52Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-116ESCITALOPRAM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, 2 package rows20241215_f2b3b385-658d-5918-e053-2a95a90afcba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNf2b3b385-658d-5918-e053-2a95a90afcba5
351249escitalopram 5 MG Oral TabletSCDf2b3b385-658d-5918-e053-2a95a90afcba5
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYf2b3b385-658d-5918-e053-2a95a90afcba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-116-265165501162690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-116-26) 2022-12-01NoNoHistorical
51655-116-525165501165230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-116-52) 2022-07-11NoNoHistorical