FDA.reportPublic FDA data

Escitalopram

Product NDC
71335-1030
11-digit product format
713351030
Labeler code
71335
Product ID
71335-1030_c4f98a44-ee66-4051-b968-0ca7711cd0b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2026-12-31

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
71335-1030-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED30104
71335-1030-2Escitalopram28 in 1 BOTTLETABLET, FILM COATED28104
71335-1030-3Escitalopram60 in 1 BOTTLETABLET, FILM COATED60104
71335-1030-4Escitalopram90 in 1 BOTTLETABLET, FILM COATED90104
71335-1030-5Escitalopram10 in 1 BOTTLETABLET, FILM COATED10104
71335-1030-6Escitalopram120 in 1 BOTTLETABLET, FILM COATED120104
71335-1030-7Escitalopram7 in 1 BOTTLETABLET, FILM COATED7104
71335-1030-8Escitalopram180 in 1 BOTTLETABLET, FILM COATED180104
71335-1030-9Escitalopram100 in 1 BOTTLETABLET, FILM COATED100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1030-3EA - Each71335-10302e861953-b606-4146-8e5b-d8733e5b19ff12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1030ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 9 package rows20250223_4966fd83-ee96-4f87-beb1-dd40d70de445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN4966fd83-ee96-4f87-beb1-dd40d70de445104
349332escitalopram 10 MG Oral TabletSCD4966fd83-ee96-4f87-beb1-dd40d70de445104
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY4966fd83-ee96-4f87-beb1-dd40d70de445104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1030-17133510300130 TABLET, FILM COATED in 1 BOTTLE (71335-1030-1) 2019-01-030000-00-00NoNoCurrent
71335-1030-27133510300228 TABLET, FILM COATED in 1 BOTTLE (71335-1030-2) 2025-01-290000-00-00NoNoCurrent
71335-1030-37133510300360 TABLET, FILM COATED in 1 BOTTLE (71335-1030-3) 2019-02-060000-00-00NoNoCurrent
71335-1030-47133510300490 TABLET, FILM COATED in 1 BOTTLE (71335-1030-4) 2018-12-190000-00-00NoNoCurrent
71335-1030-57133510300510 TABLET, FILM COATED in 1 BOTTLE (71335-1030-5) 2025-01-290000-00-00NoNoCurrent
71335-1030-671335103006120 TABLET, FILM COATED in 1 BOTTLE (71335-1030-6) 2025-01-290000-00-00NoNoCurrent
71335-1030-7713351030077 TABLET, FILM COATED in 1 BOTTLE (71335-1030-7) 2025-01-290000-00-00NoNoCurrent
71335-1030-871335103008180 TABLET, FILM COATED in 1 BOTTLE (71335-1030-8) 2025-01-290000-00-00NoNoCurrent
71335-1030-971335103009100 TABLET, FILM COATED in 1 BOTTLE (71335-1030-9) 2022-06-210000-00-00NoNoCurrent