FDA.reportPublic FDA data

Escitalopram

Product NDC
71205-344
11-digit product format
712050344
Labeler code
71205
Product ID
71205-344_9980335c-66da-49de-9880-c06f298c6eb1
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
2013-03-19
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
71205-344-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED302
71205-344-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED602
71205-344-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-344-30EA - Each71205-3445eed11a7-5244-4833-9fac-8e0b8ab623f212020-01-03
71205-344-60EA - Each71205-34471e5c985-e1ea-410f-8dad-cd268b9b274112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-344ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220513_2fb28a40-037a-49a0-b418-6c6841885cf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2fb28a40-037a-49a0-b418-6c6841885cf42
349332escitalopram 10 MG Oral TabletSCD2fb28a40-037a-49a0-b418-6c6841885cf42
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2fb28a40-037a-49a0-b418-6c6841885cf42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-344-307120503443030 TABLET, FILM COATED in 1 BOTTLE (71205-344-30) 2019-11-010000-00-00NoNoCurrent
71205-344-607120503446060 TABLET, FILM COATED in 1 BOTTLE (71205-344-60) 2019-11-010000-00-00NoNoCurrent
71205-344-907120503449090 TABLET, FILM COATED in 1 BOTTLE (71205-344-90) 2019-11-010000-00-00NoNoCurrent