FDA.reportPublic FDA data

Escitalopram

Product NDC
80425-0375
11-digit product format
804250375
Labeler code
80425
Product ID
80425-0375_14077a5d-dd96-3661-e063-6294a90a484a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA090432
Marketing category
ANDA
Marketing start
2024-03-13
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0375-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED302
80425-0375-2Escitalopram60 in 1 BOTTLETABLET, FILM COATED602
80425-0375-3Escitalopram90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0375-1EA - Each80425-0375bbe7707c-7eb8-4725-bc30-f8e6926ae5a912024-04-05
80425-0375-2EA - Each80425-0375c3c3d53b-2bee-492c-8075-4b7650af312012024-04-05
80425-0375-3EA - Each80425-0375f2778811-6ba0-4e03-896f-2e4fc66226b012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0375ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20240321_138f8703-2f13-6d07-e063-6394a90a4413.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN138f8703-2f13-6d07-e063-6394a90a44132
349332escitalopram 10 MG Oral TabletSCD138f8703-2f13-6d07-e063-6394a90a44132
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY138f8703-2f13-6d07-e063-6394a90a44132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0375-18042503750130 TABLET, FILM COATED in 1 BOTTLE (80425-0375-1) 2024-03-13NoNoCurrent
80425-0375-28042503750260 TABLET, FILM COATED in 1 BOTTLE (80425-0375-2) 2024-03-13NoNoCurrent
80425-0375-38042503750390 TABLET, FILM COATED in 1 BOTTLE (80425-0375-3) 2024-03-13NoNoCurrent