FDA.reportPublic FDA data

escitalopram

Product NDC
71335-3094
11-digit product format
713353094
Labeler code
71335
Product ID
71335-3094_f7340f48-bd07-47b8-949d-aa993b671a12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
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
71335-3094-1escitalopram30 in 1 BOTTLETABLET, FILM COATED301
71335-3094-2escitalopram28 in 1 BOTTLETABLET, FILM COATED281
71335-3094-3escitalopram60 in 1 BOTTLETABLET, FILM COATED601
71335-3094-4escitalopram90 in 1 BOTTLETABLET, FILM COATED901
71335-3094-5escitalopram10 in 1 BOTTLETABLET, FILM COATED101
71335-3094-6escitalopram120 in 1 BOTTLETABLET, FILM COATED1201
71335-3094-7escitalopram7 in 1 BOTTLETABLET, FILM COATED71
71335-3094-8escitalopram180 in 1 BOTTLETABLET, FILM COATED1801
71335-3094-9escitalopram100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN64de12e0-c35f-4082-b902-ddbaee8158a61
349332escitalopram 10 MG Oral TabletSCD64de12e0-c35f-4082-b902-ddbaee8158a61
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY64de12e0-c35f-4082-b902-ddbaee8158a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3094-17133530940130 TABLET, FILM COATED in 1 BOTTLE (71335-3094-1) 2026-02-17NoNoHistorical
71335-3094-27133530940228 TABLET, FILM COATED in 1 BOTTLE (71335-3094-2) 2026-02-17NoNoHistorical
71335-3094-37133530940360 TABLET, FILM COATED in 1 BOTTLE (71335-3094-3) 2026-02-17NoNoHistorical
71335-3094-47133530940490 TABLET, FILM COATED in 1 BOTTLE (71335-3094-4) 2026-02-17NoNoHistorical
71335-3094-57133530940510 TABLET, FILM COATED in 1 BOTTLE (71335-3094-5) 2026-02-17NoNoHistorical
71335-3094-671335309406120 TABLET, FILM COATED in 1 BOTTLE (71335-3094-6) 2026-02-17NoNoHistorical
71335-3094-7713353094077 TABLET, FILM COATED in 1 BOTTLE (71335-3094-7) 2026-02-17NoNoHistorical
71335-3094-871335309408180 TABLET, FILM COATED in 1 BOTTLE (71335-3094-8) 2026-02-17NoNoHistorical
71335-3094-971335309409100 TABLET, FILM COATED in 1 BOTTLE (71335-3094-9) 2026-02-17NoNoHistorical