FDA.reportPublic FDA data

Escitalopram

Product NDC
71205-782
11-digit product format
712050782
Labeler code
71205
Product ID
71205-782_3e3de8ea-b96b-456b-9336-69380fd2d058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078032
Marketing category
ANDA
Marketing start
2012-03-15
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
71205-782-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED301
71205-782-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED601
71205-782-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-782-30EA - Each71205-7821704e520-640d-4cb8-88f0-289f39dd1f4a12023-08-08
71205-782-60EA - Each71205-7829be2cbcc-00ea-47d0-971b-43e6aaeb97be12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-782ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230401_3e3de8ea-b96b-456b-9336-69380fd2d058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram 10 MG Oral TabletSCD3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY3e3de8ea-b96b-456b-9336-69380fd2d0581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-782-307120507823030 TABLET, FILM COATED in 1 BOTTLE (71205-782-30) 2023-03-28NoNoCurrent
71205-782-607120507826060 TABLET, FILM COATED in 1 BOTTLE (71205-782-60) 2023-03-28NoNoCurrent
71205-782-907120507829090 TABLET, FILM COATED in 1 BOTTLE (71205-782-90) 2023-03-28NoNoCurrent