FDA.reportPublic FDA data

escitalopram

Product NDC
68788-8569
11-digit product format
687888569
Labeler code
68788
Product ID
68788-8569_baac7b9e-39b4-4017-bda3-a602e6fb4e7f
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
2024-01-23
Substance
ESCITALOPRAM OXALATE
Active strength
10 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 OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

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
68788-8569-1escitalopram100 in 1 BOTTLETABLET, FILM COATED1003
68788-8569-3escitalopram30 in 1 BOTTLETABLET, FILM COATED303
68788-8569-6escitalopram60 in 1 BOTTLETABLET, FILM COATED603
68788-8569-9escitalopram90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8569-3EA - Each68788-8569ebe4a338-ab58-40b5-9a4d-15113793dcad12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8569ESCITALOPRAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250410_d16a7510-c787-4c9b-818b-1ffbcc62b3c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNd16a7510-c787-4c9b-818b-1ffbcc62b3c33
349332escitalopram 10 MG Oral TabletSCDd16a7510-c787-4c9b-818b-1ffbcc62b3c33
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd16a7510-c787-4c9b-818b-1ffbcc62b3c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8569-168788856901100 TABLET, FILM COATED in 1 BOTTLE (68788-8569-1) 2025-04-08NoNoHistorical
68788-8569-36878885690330 TABLET, FILM COATED in 1 BOTTLE (68788-8569-3) 2024-01-23NoNoHistorical
68788-8569-66878885690660 TABLET, FILM COATED in 1 BOTTLE (68788-8569-6) 2025-04-08NoNoHistorical
68788-8569-96878885690990 TABLET, FILM COATED in 1 BOTTLE (68788-8569-9) 2025-04-08NoNoHistorical