FDA.reportPublic FDA data

escitalopram

Product NDC
68788-8723
11-digit product format
687888723
Labeler code
68788
Product ID
68788-8723_2240d9ee-2752-4509-923b-27f9eb816be6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2024-08-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8723-1escitalopram100 in 1 BOTTLETABLET, FILM COATED1003
68788-8723-3escitalopram30 in 1 BOTTLETABLET, FILM COATED303
68788-8723-6escitalopram60 in 1 BOTTLETABLET, FILM COATED603
68788-8723-8escitalopram28 in 1 BOTTLETABLET, FILM COATED283
68788-8723-9escitalopram90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8723-1EA - Each68788-8723bb63bc82-83ec-4b85-9bab-40331a9e85bf12024-10-04
68788-8723-3EA - Each68788-872383db0138-1658-41bc-a96a-378c1ffbdcf412024-10-04
68788-8723-6EA - Each68788-8723d663f523-d8bb-477f-93f1-94bdbc822a6712024-10-04
68788-8723-8EA - Each68788-87239994f6ff-b601-468e-a937-2e28179affa512024-10-04
68788-8723-9EA - Each68788-872382a309f0-8522-4e85-8ae8-2658935992df12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8723ESCITALOPRAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250410_eef1c681-1972-4c3f-b4ba-cbb3388f397a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNeef1c681-1972-4c3f-b4ba-cbb3388f397a3
351250escitalopram 20 MG Oral TabletSCDeef1c681-1972-4c3f-b4ba-cbb3388f397a3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYeef1c681-1972-4c3f-b4ba-cbb3388f397a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8723-168788872301100 TABLET, FILM COATED in 1 BOTTLE (68788-8723-1) 2024-08-15NoNoHistorical
68788-8723-36878887230330 TABLET, FILM COATED in 1 BOTTLE (68788-8723-3) 2024-08-15NoNoHistorical
68788-8723-66878887230660 TABLET, FILM COATED in 1 BOTTLE (68788-8723-6) 2024-08-15NoNoHistorical
68788-8723-86878887230828 TABLET, FILM COATED in 1 BOTTLE (68788-8723-8) 2024-08-15NoNoHistorical
68788-8723-96878887230990 TABLET, FILM COATED in 1 BOTTLE (68788-8723-9) 2024-08-15NoNoHistorical