FDA.reportPublic FDA data

Escitalopram

Product NDC
60687-865
11-digit product format
606870865
Labeler code
60687
Product ID
60687-865_30c946d7-a6ce-e383-e063-6394a90a773e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078032
Marketing category
ANDA
Marketing start
2025-03-20
Substance
ESCITALOPRAM OXALATE
Active strength
5 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 OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

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
60687-865-01Escitalopram100 in 1 CARTONTABLET, FILM COATED1002
60687-865-11Escitalopram1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-865-01EA - Each60687-865fc772906-7c74-4d82-b648-081be87237df12025-03-04
60687-865-11EA - Each60687-865fe7394a8-e049-4f2e-ba59-8082242e983f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-865ESCITALOPRAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250323_de803217-6d32-4ef8-afe7-02462f37bf0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNde803217-6d32-4ef8-afe7-02462f37bf0c2
351249escitalopram 5 MG Oral TabletSCDde803217-6d32-4ef8-afe7-02462f37bf0c2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYde803217-6d32-4ef8-afe7-02462f37bf0c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-865-0160687086501100 BLISTER PACK in 1 CARTON (60687-865-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-865-11) 100 blister pack2025-03-20NoNoHistorical
60687-865-11606870865111 in 1 BLISTER PACKHistorical