FDA.reportPublic FDA data

Escitalopram

Product NDC
71205-168
11-digit product format
712050168
Labeler code
71205
Product ID
71205-168_bfd7c6f5-24c7-4491-b4f8-d501a2393fec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
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
71205-168-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED304
71205-168-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED604
71205-168-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-168-30EA - Each71205-1682ec4f678-34dc-403d-a169-dec6f1899d1012021-03-02
71205-168-60EA - Each71205-1689dd672b0-854f-459a-8f14-0c01d7d91db912019-11-12
71205-168-90EA - Each71205-16870f37f0f-5080-4423-b9bb-d82eac10002012019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-168ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220421_2d0b4839-e4d1-4e0e-9dc0-ba821f266472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram 10 MG Oral TabletSCD2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2d0b4839-e4d1-4e0e-9dc0-ba821f2664724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-168-307120501683030 TABLET, FILM COATED in 1 BOTTLE (71205-168-30) 2012-09-110000-00-00NoNoCurrent
71205-168-607120501686060 TABLET, FILM COATED in 1 BOTTLE (71205-168-60) 2012-09-110000-00-00NoNoCurrent
71205-168-907120501689090 TABLET, FILM COATED in 1 BOTTLE (71205-168-90) 2012-09-110000-00-00NoNoCurrent