FDA.reportPublic FDA data

escitalopram

Product NDC
60760-895
11-digit product format
607600895
Labeler code
60760
Product ID
60760-895_47d4373f-7797-2ab5-e063-6294a90a40c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
escitalopram
Listing expiration
2027-12-31

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
60760-895-30escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
60760-895-90escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-895-30EA - Each60760-89536a1b348-2d13-48d5-830c-e3a14ad02c0312025-06-13
60760-895-90EA - Each60760-895c3059bec-9570-4239-9e79-59fc7098899712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-895ESCITALOPRAM TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, 2 package rows20250523_1b2ec266-be5b-9265-e063-6294a90a10e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN1b2ec266-be5b-9265-e063-6294a90a10e33
349332escitalopram 10 MG Oral TabletSCD1b2ec266-be5b-9265-e063-6294a90a10e33
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY1b2ec266-be5b-9265-e063-6294a90a10e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-895-306076008953030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-895-30) 2025-05-13NoNoHistorical
60760-895-906076008959090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-895-90) 2024-06-12NoNoHistorical