FDA.reportPublic FDA data

escitalopram

Product NDC
16571-755
11-digit product format
165710755
Labeler code
16571
Product ID
16571-755_9929f3a5-d78b-4d99-bf87-d2693a9ac47e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
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
Rxcui349332, 351249, 351250

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
16571-755-01escitalopram100 in 1 BOTTLETABLET, FILM COATED1002
16571-755-10escitalopram1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-755-01EA - Each16571-755264eebfd-7612-4939-b6ed-1bce4f55cd5612023-07-06
16571-755-10EA - Each16571-7558bb339ea-8aa0-49eb-95bf-3b77665a589a12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-755ESCITALOPRAM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241114_ccbe97b5-da68-4fff-929a-240dd705fe6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN3965ca55-a5ff-4ed0-940c-363d74683fab3
351249escitalopram 5 MG Oral TabletSCD3965ca55-a5ff-4ed0-940c-363d74683fab3
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY3965ca55-a5ff-4ed0-940c-363d74683fab3
349332escitalopram oxalate 10 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram oxalate 20 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram oxalate 5 MG Oral TabletPSNd75e3b97-1ead-4e7b-9ae3-3626aede1efd2
351249escitalopram oxalate 5 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram oxalate 5 MG Oral TabletPSN3ca5da44-403b-4c9f-9dde-f5a87866836d2
349332escitalopram 10 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram 20 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram 5 MG Oral TabletSCDd75e3b97-1ead-4e7b-9ae3-3626aede1efd2
351249escitalopram 5 MG Oral TabletSCD3ca5da44-403b-4c9f-9dde-f5a87866836d2
351249escitalopram 5 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYd75e3b97-1ead-4e7b-9ae3-3626aede1efd2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY3ca5da44-403b-4c9f-9dde-f5a87866836d2
351249escitalopram oxalate 5 MG Oral TabletPSN362327ce-2dde-f657-e063-6394a90a0b631
351249escitalopram oxalate 5 MG Oral TabletPSN2d54a1cf-29cd-c485-e063-6394a90aeba31
351249escitalopram 5 MG Oral TabletSCD362327ce-2dde-f657-e063-6394a90a0b631
351249escitalopram 5 MG Oral TabletSCD2d54a1cf-29cd-c485-e063-6394a90aeba31
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY362327ce-2dde-f657-e063-6394a90a0b631
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2d54a1cf-29cd-c485-e063-6394a90aeba31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-755-0116571075501100 TABLET, FILM COATED in 1 BOTTLE (16571-755-01) 2023-06-10NoNoHistorical
16571-755-10165710755101000 TABLET, FILM COATED in 1 BOTTLE (16571-755-10) 2023-06-10NoNoHistorical