FDA.reportPublic FDA data

Escitalopram

Product NDC
68788-7461
11-digit product format
687887461
Labeler code
68788
Product ID
68788-7461_b578ecff-c411-4dfc-b7b0-0947577907ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078032
Marketing category
ANDA
Marketing start
2012-03-15
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
68788-7461-1Escitalopram100 in 1 BOTTLETABLET, FILM COATED1007
68788-7461-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED307
68788-7461-6Escitalopram60 in 1 BOTTLETABLET, FILM COATED607
68788-7461-8Escitalopram28 in 1 BOTTLETABLET, FILM COATED287
68788-7461-9Escitalopram90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7461-1EA - Each68788-746131ad5648-9f7c-45ed-9c9b-11319588c3f312020-09-14
68788-7461-3EA - Each68788-74610f2af397-dc0d-423e-b67e-d06efda603e312020-09-14
68788-7461-6EA - Each68788-7461cb0cdf0b-3abb-4b41-a7c9-c2a7a9e2d59712020-09-14
68788-7461-8EA - Each68788-746162cd240d-8bfe-4506-b23f-54ee5b1080eb12020-09-14
68788-7461-9EA - Each68788-7461486bb390-885f-4bec-8a9a-c6c03ff8e8ef12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7461ESCITALOPRAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20250410_3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f887
351250escitalopram 20 MG Oral TabletSCD3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f887
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7461-168788746101100 TABLET, FILM COATED in 1 BOTTLE (68788-7461-1) 2019-12-270000-00-00NoNoCurrent
68788-7461-36878874610330 TABLET, FILM COATED in 1 BOTTLE (68788-7461-3) 2019-12-270000-00-00NoNoCurrent
68788-7461-66878874610660 TABLET, FILM COATED in 1 BOTTLE (68788-7461-6) 2019-12-270000-00-00NoNoCurrent
68788-7461-86878874610828 TABLET, FILM COATED in 1 BOTTLE (68788-7461-8) 2019-12-270000-00-00NoNoCurrent
68788-7461-96878874610990 TABLET, FILM COATED in 1 BOTTLE (68788-7461-9) 2019-12-270000-00-00NoNoCurrent