FDA.reportPublic FDA data

Escitalopram

Product NDC
71205-325
11-digit product format
712050325
Labeler code
71205
Product ID
71205-325_65ffd6fd-533b-4e39-8fbc-5c65cd88d602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-21
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
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 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
71205-325-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED304
71205-325-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED604
71205-325-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-325-30EA - Each71205-325054d404d-07ac-4ba3-a288-550820ba73a612019-11-12
71205-325-90EA - Each71205-325b4aa598e-bd83-49e8-af43-61229b99f6a512019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-325ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20230124_1df5c652-7bad-4b07-b33b-333071bc2670.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN1df5c652-7bad-4b07-b33b-333071bc26704
351250escitalopram 20 MG Oral TabletSCD1df5c652-7bad-4b07-b33b-333071bc26704
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY1df5c652-7bad-4b07-b33b-333071bc26704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-325-307120503253030 TABLET, FILM COATED in 1 BOTTLE (71205-325-30) 2019-09-010000-00-00NoNoCurrent
71205-325-607120503256060 TABLET, FILM COATED in 1 BOTTLE (71205-325-60) 2019-09-010000-00-00NoNoCurrent
71205-325-907120503259090 TABLET, FILM COATED in 1 BOTTLE (71205-325-90) 2019-09-010000-00-00NoNoCurrent