escitalopram oxalate

Product NDC
68788-8371
11-digit product format
687888371
Labeler code
68788
Product ID
68788-8371_773ce75a-485e-41b5-b32d-336ab849dcbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090939
Marketing category
ANDA
Marketing start
2023-02-01
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 oxalate
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
68788-8371-1escitalopram oxalate100 in 1 BOTTLETABLET, FILM COATED1004
68788-8371-3escitalopram oxalate30 in 1 BOTTLETABLET, FILM COATED304
68788-8371-6escitalopram oxalate60 in 1 BOTTLETABLET, FILM COATED604
68788-8371-8escitalopram oxalate28 in 1 BOTTLETABLET, FILM COATED284
68788-8371-9escitalopram oxalate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8371-1EA - Each68788-8371770a54ff-bf3a-45c4-ab78-4aa8757e3f0812023-03-13
68788-8371-3EA - Each68788-83711ebd4021-5d69-4fb3-b222-549506ff16cd12023-03-13
68788-8371-6EA - Each68788-83717a683269-c3d9-4e69-b6f1-8dd1a59f43e512023-03-13
68788-8371-8EA - Each68788-837135135c24-f334-4284-bd9e-02c5589b670a12023-03-13
68788-8371-9EA - Each68788-83715e4075f0-973a-4d0f-924e-dcafab418abe12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8371ESCITALOPRAM OXALATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250410_7d924d16-8a10-411d-be57-97c450f56de7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN7d924d16-8a10-411d-be57-97c450f56de74
349332escitalopram 10 MG Oral TabletSCD7d924d16-8a10-411d-be57-97c450f56de74
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY7d924d16-8a10-411d-be57-97c450f56de74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8371-168788837101100 TABLET, FILM COATED in 1 BOTTLE (68788-8371-1) 2023-02-01NoNoHistorical
68788-8371-36878883710330 TABLET, FILM COATED in 1 BOTTLE (68788-8371-3) 2023-02-01NoNoHistorical
68788-8371-66878883710660 TABLET, FILM COATED in 1 BOTTLE (68788-8371-6) 2023-02-01NoNoHistorical
68788-8371-86878883710828 TABLET, FILM COATED in 1 BOTTLE (68788-8371-8) 2023-02-01NoNoHistorical
68788-8371-96878883710990 TABLET, FILM COATED in 1 BOTTLE (68788-8371-9) 2023-02-01NoNoHistorical