Escitalopram

Product NDC
51655-766
11-digit product format
516550766
Labeler code
51655
Product ID
51655-766_4973941d-2c7f-aabc-e063-6394a90aa4ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202389
Marketing category
ANDA
Marketing start
2021-07-27
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
51655-766-52Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-766ESCITALOPRAM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20241228_da7feb56-5f5a-7487-e053-2995a90a119e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNda7feb56-5f5a-7487-e053-2995a90a119e4
351249escitalopram 5 MG Oral TabletSCDda7feb56-5f5a-7487-e053-2995a90a119e4
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYda7feb56-5f5a-7487-e053-2995a90a119e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-766-525165507665230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-766-52) 2021-07-27NoNoHistorical